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A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects

Primary Purpose

IPF

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PMG1015
PMG1015 placebo
Sponsored by
Pulmongene Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IPF

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Able to understand the study procedures and method, willing to complete the study as required by the clinical study protocol, and sign the ICF; 2. Males or females, aged between 40 and 85 years of age, inclusive at signature of ICF. 3. Body weight ≥ 50 kg for males and ≥40 kg for females; 4. Diagnosis of IPF (HRCT diagnosis of UIP pattern/probable UIP pattern [as reviewed and confirmed by experts from independent imaging review team] with or without a pathologic diagnosis of UIP pattern/probable UIP pattern; if HRCT diagnosis is indeterminate for UIP, then a pathologic diagnosis of UIP pattern/probable UIP pattern is required) as defined by current American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathological examination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lung biopsy); 5. Forced vital capacity percent predicted (FVCpp) ≥45% at screening; 6. Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening; 7. Patients not receiving any approved IPF treatment (Pirfenidone or Nintedanib) for any reasons within 1 month before randomization, including those who were not tolerant or responsive to prior treatment with approved drugs (Pirfenidone or Nintedanib), or those who disagree to receive the approved IPF treatment after discussion with the investigator on the risks or benefits of such medications (Note: It's not allowed for any subject to discontinue the approved IPF treatment for inclusion into this study). Exclusion Criteria: 1. Patients with instable condition of IPF as assessed by the investigator at screening, and those with acute exacerbation of IPF during screening or within 3 months prior to randomization; 2. Patients who are likely to be lung transplant recipients within 6 months or expected to survive less than 1 year as assessed by the investigator at screening; 3. Patients with range of emphysema more than that of pulmonary fibrosis as indicated by chest HRCT (conclusion from independent imaging review shall prevail) at screening; 4. Patients accompanying with obstructive airway diseases (such as FEV1/FVC < 0.7 after bronchodilator therapy); 5. Patients accompanying with an interstitial lung disease other than IPF; 6. Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator; 7. Patients who require ≥ 15 hours of daily oxygen therapy; 8. Oxygen saturation at rest in room air measured by a finger pulse oximeter <90% (0-1500 meters above the sea level) or <85% (>1500 meters above the sea level) at screening; 9. Patients who received corticosteroids (Prednisone Acetate Tablets > 15 mg/day or an equivalent dose of other corticosteroids) within 1 month prior to screening; 10. Patients who received any cytotoxic drug, immunosuppressant, cytokine regulator, or receptor antagonist (including but not limited to Methotrexate, Azathioprine, Mycophenolate Mofetil, Cyclophosphamide, Cyclosporin) within 4 weeks prior to screening; 11. Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening; 12. Patients accompanying with other uncontrolled underlying diseases (congestive heart failure, acute myocardial infarction, unstable angina pectoris, hemorrhagic stroke, or ischemic stroke categorized as New York Heart Association [NYHA] Class III, or IV, as well as pulmonary arterial hypertension requiring intervention within 6 months prior to screening), for which the patient is not considered suitable for the study as assessed by the investigator; 13. Patients who had active tuberculosis within 12 months prior to screening, or clinical symptoms of bacterial, viral, fungal or microbial infections requiring intervention within 4 weeks prior to randomization; 14. Patients with coronavirus disease-2019 (COVID-19) diagnosis within 1 month prior to screening and/or at screening (COVID-19 nucleic acid test is not a required procedure of the study, but may be performed if necessary); 15. Patients who were vaccinated or plan to get vaccinated against COVID-19 and other diseases within 1 month prior to screening and up to 1 month after the last dose; 16. Patients with history of malignancies (excluding recovered basal cell carcinoma and cervical carcinoma in situ) within 5 years prior to screening, or under evaluation of any potential malignancies; 17. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2×Upper Limit of Normal (ULN) or Total Bilirubin ≥1.5×ULN; 18. Serum creatinine ≥1.5×ULN; 19. Patients with active hepatitis, syphilis, or positive for HIV antibody; 20. Patients who had a major surgery (under general anesthesia) within 3 months prior to screening, or plan to undergo a surgery during the study, which may affect the evaluation of the study endpoints as assessed by the investigator; 21. Patients who participated in any clinical trials (of, including, other investigational drugs/devices) within 3 months prior to screening, or within 5 half-lives at screening; 22. A former smoker who quitted for ≤ 3 months, or unable to quit smoking throughout the study; 23. A suspected or confirmed alcohol or drug abuser; 24. Patients who have known allergic reaction to the investigational product or its APIs, or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients; 25. Pregnant or lactating women; female subjects who plan to become pregnant during the study, or patients who are not willing to take contraceptive measures as required by the protocol during the study; 26. Other conditions that preclude the patient from participating in the study as assessed by the investigator.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Tongji Hospital, Tongji Medical College of HUSTRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Shanghai Chest HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo Comparator

Arm Description

Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (8 of whom receiving the investigational product) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.

Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (2 of whom receiving placebo) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.

Outcomes

Primary Outcome Measures

Incidence and severity of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring during the study
Based on the currently available non-clinical data and disclosed clinical data, the adverse events that may occur during the study include: Infusion-related hypersensitivity reaction; Headache; Symptoms of the digestive system: Nausea, diarrhoea; Elevated liver enzymes: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, and Gamma-glutamyl transpeptidase increased; Abnormal blood lipids: Blood triglycerides increased; Other unexpected adverse reactions. Criteria for Serious Adverse Events (SAEs): Results in death Is life-threatening Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Death due to disease progression Important medical event
Assessment of vital sign measurement results-respiratory rate
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in respiratory rate (breaths/min).
Assessment of vital sign measurement results-pulse rate
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pulse rate (beats/min).
Assessment of vital sign measurement results-body temperature
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in body temperature (℃).
Assessment of vital sign measurement results-sitting blood pressure
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sitting blood pressure (mmHg).
Title: Title: Assessment of Physical Examination results - skin
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in skin (normal, abnormal).
Title: Assessment of Physical Examination results - head
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in head (normal, abnormal).
Title: Assessment of Physical Examination results - neck
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neck (normal, abnormal).
Assessment of Physical Examination results - oral cavity
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in oral cavity (normal, abnormal).
Assessment of Physical Examination results - chest
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chest (normal, abnormal).
Assessment of Physical Examination results - abdomen
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in abdomen (normal, abnormal).
Assessment of Physical Examination results - lymph nodes
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in lymph nodes (normal, abnormal).
Assessment of Physical Examination results - neurological
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neurological (normal, abnormal).
Assessment of Physical Examination results - psychiatric status
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in psychiatric status (normal, abnormal).
Assessment of Physical Examination results - extremities
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in extremities (normal, abnormal).
Assessment of Physical Examination results - weight
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in weight (kilograms).
Assessment of Physical Examination results - height
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in height (meters).
Assessment of 12-lead electrocardiogram (ECG) results - heart rate
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in heart rate (beats per minute).
Assessment of 12-lead electrocardiogram (ECG) results - RR interval
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in RR interval (milliseconds).
Assessment of 12-lead electrocardiogram (ECG) results - PR interval
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in PR interval (milliseconds).
Assessment of 12-lead electrocardiogram (ECG) results - QRS complex
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QRS complex (milliseconds).
Assessment of 12-lead electrocardiogram (ECG) results - QTc interval
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QTc interval (milliseconds).
Assessment of Hematology results - blood cell counts
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood cell counts (cells/μL).
Assessment of Hematology results - white blood cell differential counts
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cell differential counts (including eosinophil count and percentage, basophil count and percentage, neutrophil count and percentage, lymphocyte and monocyte count and percentage).
Assessment of Hematology results - red blood cell count
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cell count (cells/μL).
Assessment of Hematology results - hematocrit
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hematocrit (%).
Assessment of Hematology results - hemoglobin content
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hemoglobin content (g/dL).
Assessment of Hematology results - platelet count
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in platelet count (cells/μL).
Assessment of Urinalysis results - pH
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pH.
Assessment of Urinalysis results - specific gravity
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in specific gravity.
Assessment of Urinalysis results - protein
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in protein (negative/+/++/+++).
Assessment of Urinalysis results - glucose
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in glucose (negative/+/++/+++).
Assessment of Urinalysis results - ketones
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in ketones (negative/+/++/+++).
Assessment of Urinalysis results - red blood cells
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cells (cells/HP).
Assessment of Urinalysis results - white blood cells
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cells (cells/HP).
Assessment of Blood biochemistry results - blood glucose
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood glucose (mmol/L).
Assessment of Blood biochemistry results - triglycerides
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in triglycerides (mmol/L).
Assessment of Blood biochemistry results - total cholesterol
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total cholesterol (mmol/L).
Assessment of Blood biochemistry results - direct bilirubin
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in direct bilirubin (μmol/L).
Assessment of Blood biochemistry results - alanine aminotransferase
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in alanine aminotransferase (ALT,U/L).
Assessment of Blood biochemistry results - albumin quantification
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in albumin quantification (g/dL).
Assessment of Blood biochemistry results - total bilirubin
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total bilirubin (μmol/L).
Assessment of Blood biochemistry results - creatinine
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatinine (μmol/L).
Assessment of Blood biochemistry results - urea/urea nitrogen
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in urea/urea nitrogen (mmol/L).
Assessment of Blood biochemistry results - uric acid
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in uric acid (μmol/L).
Assessment of Blood biochemistry results - potassium
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in potassium (mmol/L).
Assessment of Blood biochemistry results - sodium
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sodium (mmol/L).
Assessment of Blood biochemistry results - chloride
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chloride (mmol/L).
Assessment of Blood biochemistry results - total calcium
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total calcium (mmol/L).
Assessment of Blood biochemistry results - inorganic phosphorus
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in inorganic phosphorus (mmol/L).
Assessment of Blood biochemistry results - creatine kinase
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase (CK,U/L).
Assessment of Blood biochemistry results - creatine kinase-MB
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase-MB (CK-MB,ng/mL).
Assessment of Blood biochemistry results - troponin I
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in troponin I (TnI,ng/mL).
Assessment of Blood biochemistry results - myoglobin
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in myoglobin (ng/mL).
Assessment of Coagulation results- prothrombin time
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in prothrombin time (PT, seconds).
Assessment of Coagulation results- activated partial thromboplastin time
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in activated partial thromboplastin time (APTT, seconds).
Assessment of Coagulation results- international normalized ratio
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in international normalized ratio (INR).
Assessment of Coagulation results- fibrinogen
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in fibrinogen (mg/dL).
Assessment of pulmonary function test results-forced vital capacity (FVC)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced vital capacity (FVC) (L) will be assessed at baseline and the second dose, and after the last dose.
Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced vital capacity percent predicted (FVCpp) (%) will be assessed at baseline and the second dose, and after the last dose.
Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced expiratory volume in 1 second (FEV1) (L) will be assessed at baseline and the second dose, and after the last dose.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be assessed at baseline and the second dose, and after the last dose.
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp)
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be assessed at baseline and the second dose, and after the last dose.
Evaluate chest high-resolution computed tomography (HRCT) results.
Chest HRCT is a type of CT used for diagnosing diseases of the chest. The HRCT diagnosis should include UIP-type/maybe UIP-type (confirmed by an independent imaging review group expert) with or without pathological UIP-type/maybe UIP-type; non-definitive UIP diagnosed by HRCT requires pathological UIP-type/maybe UIP-type (pathology refers to cryopreserved lung biopsy or surgical/thoracoscopic lung biopsy). Chest HRCT will be performed at screening and each dose, and after the last dose, to assess the changes from baseline to post-dose in Chest HRCT.

Secondary Outcome Measures

Evaluate the pharmacokinetic (PK) parameter of the area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Evaluate the PK parameter of the area under the concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Evaluate the PK parameter of the area under the concentration-time curve from time zero to the dosing interval (AUC0-tau) of PMG1015.
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Evaluate the PK parameter of the maximum concentration (Cmax) of PMG1015.
Cmax refers to the highest concentration of a drug in the blood after administration, which is related to the dose, route of administration, dosing frequency, and time to reach the peak concentration.
Evaluate the PK parameter of the time to reach the maximum concentration (Tmax) of PMG1015.
Tmax refers to the time when a drug reaches its maximum concentration and exhibits its maximum effect in the body.
Evaluate the PK parameter of the elimination half-life (t1/2) of PMG1015.
t1/2 refers to the time required for the drug concentration in the blood to decrease by half.
Evaluate the PK parameter of the clearance rate (CL) of PMG1015.
CL is the volume of liquid containing a drug that is completely eliminated by the excretory organs per unit time, and its unit is usually mL·(min·kg)-1 or L·(h·kg)-1.
Evaluate the PK parameter of the distribution volume (Vz) of PMG1015.
Vz is a pharmacokinetic parameter that reflects the extent of drug distribution in various tissues in the body.
Evaluate the PK parameter of the elimination rate constant (λz) of PMG1015.
λz refers to the ratio of the amount of compound eliminated per unit time to the total amount, with its unit being the reciprocal of time.
Relationship between the dose and exposure.
Dose refers to the quantity of drug administered at one time that produces a therapeutic effect.
Incidence of PMG1015-induced and PMG1015-enhanced ADAs.
Immunogenicity assessment is mainly based on anti-drug antibodies (ADAs), including the incidence of PMG1015-induced and PMG1015-enhanced ADAs.

Full Information

First Posted
April 11, 2023
Last Updated
July 19, 2023
Sponsor
Pulmongene Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05895565
Brief Title
A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects
Official Title
A Phase Ib, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PMG1015 Injection After Multiple Ascending Doses in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
May 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmongene Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Idiopathic Pulmonary Fibrosis (IPF): It is a progressive and fatal fibrosing interstitial lung disease of unknown etiology, with a median survival of only 2 to 3 years. Epidemiology of IPF (with reference to the international epidemiological studies due to the lack of accurate epidemiological data in China): the incidence was 2 to 30 per 100,000 person years, and the prevalence was 10 to 60 per 100,000. More males suffer from IPF than females. In population aged more than 65 years, the estimated prevalence was up to 400 per 100,000. Medications for IPF: Currently there is no medication with definitely significant efficacy (such as slowing down the disease progression). However, the following drugs can be used as appropriate based on the results of randomized and controlled clinical trials conducted in recent years and taking account of the patients' actual clinical conditions. Pirfenidone: It has been proven to remarkably slow down forced vital capacity (FVC) decline and reduce the risk of death to a certain degree, with the side effects of photosensitivity, asthenia, rash, stomach upset, and anorexia. Pirfenidone is recommended for IPF patients accompanying with mild to moderate pulmonary dysfunction in clinical practice. Nintedanib: It could remarkably slow down the absolute value of FVC decline in IPF patients, thereby slowing down the disease progression to a certain degree. The most common adverse reaction of Nintedanib is diarrhoea. Future therapeutic strategies for IPF: A multi-drug concomitant therapy against different therapeutic targets for pulmonary fibrosis may be a potential strategy, among which, the research and development of anti-fibrotic drugs may be most valuable in treatment of this disease, with promising potentials of halting or reversing disease progression, extending the life expectancy, improving the quality of life, and reducing the side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IPF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
At screening, each subject will be identified by a screening number, and each screened subject shall have a unique screening number. Each subject will be assigned with a screening number after signing the informed consent form (ICF). Eligible subjects will be randomized and enter the administration and observation period to receive the study drug (PMG1015 or placebo), and will be assigned with a corresponding subject ID and a drug number. The randomization scheme will be generated using the Rava RTSM system.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (8 of whom receiving the investigational product) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (2 of whom receiving placebo) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.
Intervention Type
Drug
Intervention Name(s)
PMG1015
Intervention Description
Strength: 100 mg/2 mL/vial. Dosage and Administration: Intravenous infusion of PMG1015 at 15 mg/kg, 30 mg/kg and 40 mg/kg for 30 min (±5 min), once every 4 weeks, for 3 doses.
Intervention Type
Drug
Intervention Name(s)
PMG1015 placebo
Intervention Description
The placebo injection of PMG1015 contains the same excipients as PMG1015 Injection, only without the active substance. Strength: 2 mL/vial. Dosage and Administration: A single dose of placebo. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.
Primary Outcome Measure Information:
Title
Incidence and severity of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring during the study
Description
Based on the currently available non-clinical data and disclosed clinical data, the adverse events that may occur during the study include: Infusion-related hypersensitivity reaction; Headache; Symptoms of the digestive system: Nausea, diarrhoea; Elevated liver enzymes: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, and Gamma-glutamyl transpeptidase increased; Abnormal blood lipids: Blood triglycerides increased; Other unexpected adverse reactions. Criteria for Serious Adverse Events (SAEs): Results in death Is life-threatening Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Death due to disease progression Important medical event
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of vital sign measurement results-respiratory rate
Description
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in respiratory rate (breaths/min).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of vital sign measurement results-pulse rate
Description
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pulse rate (beats/min).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of vital sign measurement results-body temperature
Description
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in body temperature (℃).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of vital sign measurement results-sitting blood pressure
Description
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sitting blood pressure (mmHg).
Time Frame
Throughout the study,approximately 2 years.
Title
Title: Title: Assessment of Physical Examination results - skin
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in skin (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Title: Assessment of Physical Examination results - head
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in head (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Title: Assessment of Physical Examination results - neck
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neck (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - oral cavity
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in oral cavity (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - chest
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chest (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - abdomen
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in abdomen (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - lymph nodes
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in lymph nodes (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - neurological
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neurological (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - psychiatric status
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in psychiatric status (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - extremities
Description
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in extremities (normal, abnormal).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - weight
Description
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in weight (kilograms).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Physical Examination results - height
Description
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in height (meters).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of 12-lead electrocardiogram (ECG) results - heart rate
Description
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in heart rate (beats per minute).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of 12-lead electrocardiogram (ECG) results - RR interval
Description
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in RR interval (milliseconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of 12-lead electrocardiogram (ECG) results - PR interval
Description
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in PR interval (milliseconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of 12-lead electrocardiogram (ECG) results - QRS complex
Description
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QRS complex (milliseconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of 12-lead electrocardiogram (ECG) results - QTc interval
Description
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QTc interval (milliseconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - blood cell counts
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood cell counts (cells/μL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - white blood cell differential counts
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cell differential counts (including eosinophil count and percentage, basophil count and percentage, neutrophil count and percentage, lymphocyte and monocyte count and percentage).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - red blood cell count
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cell count (cells/μL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - hematocrit
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hematocrit (%).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - hemoglobin content
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hemoglobin content (g/dL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Hematology results - platelet count
Description
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in platelet count (cells/μL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - pH
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pH.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - specific gravity
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in specific gravity.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - protein
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in protein (negative/+/++/+++).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - glucose
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in glucose (negative/+/++/+++).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - ketones
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in ketones (negative/+/++/+++).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - red blood cells
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cells (cells/HP).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Urinalysis results - white blood cells
Description
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cells (cells/HP).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - blood glucose
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood glucose (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - triglycerides
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in triglycerides (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - total cholesterol
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total cholesterol (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - direct bilirubin
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in direct bilirubin (μmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - alanine aminotransferase
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in alanine aminotransferase (ALT,U/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - albumin quantification
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in albumin quantification (g/dL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - total bilirubin
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total bilirubin (μmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - creatinine
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatinine (μmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - urea/urea nitrogen
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in urea/urea nitrogen (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - uric acid
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in uric acid (μmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - potassium
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in potassium (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - sodium
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sodium (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - chloride
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chloride (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - total calcium
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total calcium (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - inorganic phosphorus
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in inorganic phosphorus (mmol/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - creatine kinase
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase (CK,U/L).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - creatine kinase-MB
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase-MB (CK-MB,ng/mL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - troponin I
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in troponin I (TnI,ng/mL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Blood biochemistry results - myoglobin
Description
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in myoglobin (ng/mL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Coagulation results- prothrombin time
Description
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in prothrombin time (PT, seconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Coagulation results- activated partial thromboplastin time
Description
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in activated partial thromboplastin time (APTT, seconds).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Coagulation results- international normalized ratio
Description
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in international normalized ratio (INR).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of Coagulation results- fibrinogen
Description
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in fibrinogen (mg/dL).
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of pulmonary function test results-forced vital capacity (FVC)
Description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced vital capacity (FVC) (L) will be assessed at baseline and the second dose, and after the last dose.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp)
Description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced vital capacity percent predicted (FVCpp) (%) will be assessed at baseline and the second dose, and after the last dose.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1)
Description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in forced expiratory volume in 1 second (FEV1) (L) will be assessed at baseline and the second dose, and after the last dose.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO)
Description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be assessed at baseline and the second dose, and after the last dose.
Time Frame
Throughout the study,approximately 2 years.
Title
Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp)
Description
Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be assessed at baseline and the second dose, and after the last dose.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate chest high-resolution computed tomography (HRCT) results.
Description
Chest HRCT is a type of CT used for diagnosing diseases of the chest. The HRCT diagnosis should include UIP-type/maybe UIP-type (confirmed by an independent imaging review group expert) with or without pathological UIP-type/maybe UIP-type; non-definitive UIP diagnosed by HRCT requires pathological UIP-type/maybe UIP-type (pathology refers to cryopreserved lung biopsy or surgical/thoracoscopic lung biopsy). Chest HRCT will be performed at screening and each dose, and after the last dose, to assess the changes from baseline to post-dose in Chest HRCT.
Time Frame
Throughout the study,approximately 2 years.
Secondary Outcome Measure Information:
Title
Evaluate the pharmacokinetic (PK) parameter of the area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015.
Description
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the area under the concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.
Description
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the area under the concentration-time curve from time zero to the dosing interval (AUC0-tau) of PMG1015.
Description
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the maximum concentration (Cmax) of PMG1015.
Description
Cmax refers to the highest concentration of a drug in the blood after administration, which is related to the dose, route of administration, dosing frequency, and time to reach the peak concentration.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the time to reach the maximum concentration (Tmax) of PMG1015.
Description
Tmax refers to the time when a drug reaches its maximum concentration and exhibits its maximum effect in the body.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the elimination half-life (t1/2) of PMG1015.
Description
t1/2 refers to the time required for the drug concentration in the blood to decrease by half.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the clearance rate (CL) of PMG1015.
Description
CL is the volume of liquid containing a drug that is completely eliminated by the excretory organs per unit time, and its unit is usually mL·(min·kg)-1 or L·(h·kg)-1.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the distribution volume (Vz) of PMG1015.
Description
Vz is a pharmacokinetic parameter that reflects the extent of drug distribution in various tissues in the body.
Time Frame
Throughout the study,approximately 2 years.
Title
Evaluate the PK parameter of the elimination rate constant (λz) of PMG1015.
Description
λz refers to the ratio of the amount of compound eliminated per unit time to the total amount, with its unit being the reciprocal of time.
Time Frame
Throughout the study,approximately 2 years.
Title
Relationship between the dose and exposure.
Description
Dose refers to the quantity of drug administered at one time that produces a therapeutic effect.
Time Frame
Throughout the study,approximately 2 years.
Title
Incidence of PMG1015-induced and PMG1015-enhanced ADAs.
Description
Immunogenicity assessment is mainly based on anti-drug antibodies (ADAs), including the incidence of PMG1015-induced and PMG1015-enhanced ADAs.
Time Frame
Throughout the study,approximately 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Able to understand the study procedures and method, willing to complete the study as required by the clinical study protocol, and sign the ICF; 2. Males or females, aged between 40 and 85 years of age, inclusive at signature of ICF. 3. Body weight ≥ 50 kg for males and ≥40 kg for females; 4. Diagnosis of IPF (HRCT diagnosis of UIP pattern/probable UIP pattern [as reviewed and confirmed by experts from independent imaging review team] with or without a pathologic diagnosis of UIP pattern/probable UIP pattern; if HRCT diagnosis is indeterminate for UIP, then a pathologic diagnosis of UIP pattern/probable UIP pattern is required) as defined by current American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathological examination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lung biopsy); 5. Forced vital capacity percent predicted (FVCpp) ≥45% at screening; 6. Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening; 7. Patients not receiving any approved IPF treatment (Pirfenidone or Nintedanib) for any reasons within 1 month before randomization, including those who were not tolerant or responsive to prior treatment with approved drugs (Pirfenidone or Nintedanib), or those who disagree to receive the approved IPF treatment after discussion with the investigator on the risks or benefits of such medications (Note: It's not allowed for any subject to discontinue the approved IPF treatment for inclusion into this study). Exclusion Criteria: 1. Patients with instable condition of IPF as assessed by the investigator at screening, and those with acute exacerbation of IPF during screening or within 3 months prior to randomization; 2. Patients who are likely to be lung transplant recipients within 6 months or expected to survive less than 1 year as assessed by the investigator at screening; 3. Patients with range of emphysema more than that of pulmonary fibrosis as indicated by chest HRCT (conclusion from independent imaging review shall prevail) at screening; 4. Patients accompanying with obstructive airway diseases (such as FEV1/FVC < 0.7 after bronchodilator therapy); 5. Patients accompanying with an interstitial lung disease other than IPF; 6. Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator; 7. Patients who require ≥ 15 hours of daily oxygen therapy; 8. Oxygen saturation at rest in room air measured by a finger pulse oximeter <90% (0-1500 meters above the sea level) or <85% (>1500 meters above the sea level) at screening; 9. Patients who received corticosteroids (Prednisone Acetate Tablets > 15 mg/day or an equivalent dose of other corticosteroids) within 1 month prior to screening; 10. Patients who received any cytotoxic drug, immunosuppressant, cytokine regulator, or receptor antagonist (including but not limited to Methotrexate, Azathioprine, Mycophenolate Mofetil, Cyclophosphamide, Cyclosporin) within 4 weeks prior to screening; 11. Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening; 12. Patients accompanying with other uncontrolled underlying diseases (congestive heart failure, acute myocardial infarction, unstable angina pectoris, hemorrhagic stroke, or ischemic stroke categorized as New York Heart Association [NYHA] Class III, or IV, as well as pulmonary arterial hypertension requiring intervention within 6 months prior to screening), for which the patient is not considered suitable for the study as assessed by the investigator; 13. Patients who had active tuberculosis within 12 months prior to screening, or clinical symptoms of bacterial, viral, fungal or microbial infections requiring intervention within 4 weeks prior to randomization; 14. Patients with coronavirus disease-2019 (COVID-19) diagnosis within 1 month prior to screening and/or at screening (COVID-19 nucleic acid test is not a required procedure of the study, but may be performed if necessary); 15. Patients who were vaccinated or plan to get vaccinated against COVID-19 and other diseases within 1 month prior to screening and up to 1 month after the last dose; 16. Patients with history of malignancies (excluding recovered basal cell carcinoma and cervical carcinoma in situ) within 5 years prior to screening, or under evaluation of any potential malignancies; 17. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2×Upper Limit of Normal (ULN) or Total Bilirubin ≥1.5×ULN; 18. Serum creatinine ≥1.5×ULN; 19. Patients with active hepatitis, syphilis, or positive for HIV antibody; 20. Patients who had a major surgery (under general anesthesia) within 3 months prior to screening, or plan to undergo a surgery during the study, which may affect the evaluation of the study endpoints as assessed by the investigator; 21. Patients who participated in any clinical trials (of, including, other investigational drugs/devices) within 3 months prior to screening, or within 5 half-lives at screening; 22. A former smoker who quitted for ≤ 3 months, or unable to quit smoking throughout the study; 23. A suspected or confirmed alcohol or drug abuser; 24. Patients who have known allergic reaction to the investigational product or its APIs, or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients; 25. Pregnant or lactating women; female subjects who plan to become pregnant during the study, or patients who are not willing to take contraceptive measures as required by the protocol during the study; 26. Other conditions that preclude the patient from participating in the study as assessed by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaohui Wang, BA
Phone
86-010-69776688
Email
yaohui_wang@pulmongene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wang, PhD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huaping Dai, PhD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siyuan Xi
Phone
86-010-84206086
Email
ZRYHYYGCPEC@126.com
First Name & Middle Initial & Last Name & Degree
Chen Wang, PhD
First Name & Middle Initial & Last Name & Degree
Huaping Dai, PhD
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Luo, PhD
Phone
13710658121
Email
luoqunx@163.com
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilan Zhang, PhD
Phone
86-15391532171
Email
huilanz_76@163.com
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengshu Cao, PhD
Phone
86-13770838003
Email
mengshucao@126.com
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Li, PhD
Phone
86-18017321517
Email
Lifeng741@aliyun.com
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinfu Xu, PhD
Phone
86-13321922898
Email
jfxucn@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects

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