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.