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A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQH2722 injection
Placebo to match TQH2722
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1 The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions.
  • 2 Aged 18 ~ 60 years old (including the critical value), both male and female;
  • 3 ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2)
  • 4 The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study;
  • 5 The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential;
  • 6 Normal physical examination, vital signs or abnormal physical examination, vital signs without clinical significance

Exclusion Criteria:

  • 1 Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening;
  • 2 Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial;
  • 3 People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period;
  • 4 Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP);
  • 5 Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization;
  • 6 People who received surgical operation within 4 weeks prior to screening, or planned to receive surgical operation during the study period;
  • 7 People who participated in other clinical trials and took the study drug within 3 months before screening;
  • 8 Received immunoglobulins or blood products within 30 days prior to randomization;
  • 9 Blood loss or blood donation of more than 400 mL within 2 months prior to randomization;
  • 10 People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness;
  • 11 A history of allergic reactions to another therapeutic monoclonal antibody or biologic agent therapy, or any clear history of drug or food allergies, particularly those with allergies to similar components to the drug in this trial;
  • 12 People who have received or are planning to receive live-reduced or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period);
  • 13 Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 6 months prior to randomization and the entire study period (including the follow-up period);
  • 14 People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening and the entire study period (including the follow-up period), or those who tested positive for alcohol breath;
  • 15 People with a history of substance abuse or positive urine drug screening;
  • 16 Received any marketed or research biologics within 4 months or 5 half-lives (whichever is longer) prior to randomization;
  • 17 Taking any prescription, over-the-counter and herbal medicines within 4 weeks prior to randomization, with the exception of vitamin products;
  • 18 Use of any systemic cytotoxicity or systemic immunosuppressants within 6 months prior to randomization or during the study period, or any local cytotoxin or local immunosuppressive drug within 30 days or 5 half-life periods (whichever is longer) prior to randomization or during the study period;
  • 19 Parasitic infection is associated and is excluded if any of the following are met:

    • During the screening period, the stool routinely checks positive for eggs;
    • History of parasitic infection within 6 months prior to the screening period;
    • Have traveled or planned to travel to endemic parasitic infection areas (including but not limited to Southeast and South-West Asia, South America and Africa) within 6 months prior to screening visits;
  • 20 Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.

Sites / Locations

  • The Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TQH2722 injection

Placebo to match TQH2722

Arm Description

Participants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.

Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.

Outcomes

Primary Outcome Measures

Adverse events (AE)
Incidence and severity of adverse events (AE) .
Serious adverse events (SAE)
Incidence and severity of Serious adverse events (SAE).
Blood biochemistry
Abnormal indicators of blood biochemistry.
Coagulation function
Abnormal indicators of coagulation function.
Blood routine
Abnormal indicators of blood routine.
Urinalysis
Abnormal indicators of urinalysis.
Blood pressure
Abnormal values of blood pressure
Pulse
Abnormal values of blood pulse.
Body temperature
Abnormal values of blood body temperature.
Skin
Examination of the skin.
Mucous membranes
Examination of the mucous membranes.
Lymph nodes
Examination of the lymph nodes.
Head
Examination of the head.
Neck
Examination of the neck.
Chest
Examination of the chest.
Abdomen
Examination of the abdomen.
Spine
Examination of the spine.
Limbs
Examination of the limbs.
12-lead electrocardiogram
Abnormal values of 12-lead electrocardiogram

Secondary Outcome Measures

Maximum Concentration(Cmax)
Maximum Concentration
Minimum Concentration(Cmax)
Minimum Concentration
Time to maximum concentration(Tmax)
Time to maximum concentration following drug administration
Area under the drug-time curve(AUC)
Area under the drug-time curve
Apparent terminal elimination half-life(t1/2)
Apparent terminal elimination half-life following drug administration
Apparent volume of distribution(Vd/F)
Apparent volume of distribution
Clearance rate(CL/F)
Clearance rate
Immunoglobulin E(IgE)
Percentage of changes in serum IgE
Thymus activation regulates chemokines(TARC)
Percentage of changes in serum TARC
Anti-drug antibody (ADA)
Incidence and titer of anti-drug antibody
Neutralizing Antibody(Nab)
Incidence of Neutralizing Antibody
Injection site response
Injection site response assessment

Full Information

First Posted
May 24, 2022
Last Updated
June 5, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05409326
Brief Title
A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
Official Title
A Phase I Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQH2722 injection
Arm Type
Experimental
Arm Description
Participants will receive single dose of TQH2722 injection under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of TQH2722 injection once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.
Arm Title
Placebo to match TQH2722
Arm Type
Placebo Comparator
Arm Description
Participants will receive single dose of matching placebo under fasted condition (Single Ascending Dose(SAD) Cohorts 50mg, 150mg, 300mg, 600mg, 1200mg) on Day 1, or will receive multiple doses of matching placebo once every 14 days under fasted condition (Multiple-Dose Administration (MAD) Cohort 150mg, 600mg) on Day 1-43.
Intervention Type
Drug
Intervention Name(s)
TQH2722 injection
Intervention Description
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
Intervention Type
Drug
Intervention Name(s)
Placebo to match TQH2722
Intervention Description
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
Primary Outcome Measure Information:
Title
Adverse events (AE)
Description
Incidence and severity of adverse events (AE) .
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Serious adverse events (SAE)
Description
Incidence and severity of Serious adverse events (SAE).
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Blood biochemistry
Description
Abnormal indicators of blood biochemistry.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Coagulation function
Description
Abnormal indicators of coagulation function.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Blood routine
Description
Abnormal indicators of blood routine.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Urinalysis
Description
Abnormal indicators of urinalysis.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Blood pressure
Description
Abnormal values of blood pressure
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Pulse
Description
Abnormal values of blood pulse.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Body temperature
Description
Abnormal values of blood body temperature.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Skin
Description
Examination of the skin.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Mucous membranes
Description
Examination of the mucous membranes.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Lymph nodes
Description
Examination of the lymph nodes.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Head
Description
Examination of the head.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Neck
Description
Examination of the neck.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Chest
Description
Examination of the chest.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Abdomen
Description
Examination of the abdomen.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Spine
Description
Examination of the spine.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
Limbs
Description
Examination of the limbs.
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Title
12-lead electrocardiogram
Description
Abnormal values of 12-lead electrocardiogram
Time Frame
From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 99 days.
Secondary Outcome Measure Information:
Title
Maximum Concentration(Cmax)
Description
Maximum Concentration
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Minimum Concentration(Cmax)
Description
Minimum Concentration
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Time to maximum concentration(Tmax)
Description
Time to maximum concentration following drug administration
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Area under the drug-time curve(AUC)
Description
Area under the drug-time curve
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Apparent terminal elimination half-life(t1/2)
Description
Apparent terminal elimination half-life following drug administration
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Apparent volume of distribution(Vd/F)
Description
Apparent volume of distribution
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose.
Title
Clearance rate(CL/F)
Description
Clearance rate
Time Frame
SAD:Before administration,1,4,8,12,24,72,168,240,336,408,504,576,672,840,1008,1176,1344 hours postdose. MAD:Before every administration,1,4,8,12,24,72,168,504,840,1009,1012,1016,1020,1032,1080,1176,1334,1512,1680,1848,2016,2352 hours postdose
Title
Immunoglobulin E(IgE)
Description
Percentage of changes in serum IgE
Time Frame
SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Title
Thymus activation regulates chemokines(TARC)
Description
Percentage of changes in serum TARC
Time Frame
SAD:Before administration,168,336,504,672,1008,1344 hours after administration. MAD:Before every administration,336,672,1344 hours after the last administration.
Title
Anti-drug antibody (ADA)
Description
Incidence and titer of anti-drug antibody
Time Frame
SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Title
Neutralizing Antibody(Nab)
Description
Incidence of Neutralizing Antibody
Time Frame
SAD:Before administration,336,1344 hours after administration. MAD:Before the first administration;Before the third administration;336,1344 hours after the last administration.
Title
Injection site response
Description
Injection site response assessment
Time Frame
Before administration,0.5,1,3,6 hours after administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1 The informed consent was signed before the trial, fully understood the purpose and process of the trial and the possible adverse reactions. 2 Aged 18 ~ 60 years old (including the critical value), both male and female; 3 ≥ 45 kg for females and ≥ 50 kg for males with a body mass index (BMI) between 19 and 26 kg/m2 inclusive, BMI = weight (kg)/height2 (m2) 4 The subject is able to communicate well with the investigator, voluntary and able to understand and follow protocol procedures to complete the study; 5 The subject agrees not to have a childbearing plan from the date of signing the informed consent form to 6 months after the last dose, and must use effective non-drug contraception with a partner of childbearing potential; 6 Normal physical examination, vital signs or abnormal physical examination, vital signs without clinical significance Exclusion Criteria: 1 Females who are pregnant, lactating or have unprotected sex within two weeks prior to screening; 2 Past medical history or current cardiac, endocrine, metabolic, renal, hepatic, gastrointestinal, skin, infection, hematological, neurological or psychiatric diseases/abnormalities, or related chronic diseases, or acute diseases, and the investigator evaluated that the subject was not suitable for the trial; 3 People who have abnormal and clinically significant results in vital signs, physical examination, laboratory tests, eye examination, 12-lead ECG and X-ray during screening period; 4 Subjects Positive for Any of Hepatitis B Virus Surface Antigen (HBsAg), Hepatitis C Virus Antibody (Anti-HCV), Human Immunodeficiency Virus Antibody (Anti-HIV), and Treponema Pallidum Antibody (Anti-TP); 5 Clinically significant respiratory infection requiring antibiotic or antiviral therapy within 7 days prior to randomization; 6 People who received surgical operation within 4 weeks prior to screening, or planned to receive surgical operation during the study period; 7 People who participated in other clinical trials and took the study drug within 3 months before screening; 8 Received immunoglobulins or blood products within 30 days prior to randomization; 9 Blood loss or blood donation of more than 400 mL within 2 months prior to randomization; 10 People who have potential difficulty in blood collection, or have a history of halo needles or blood sickness; 11 A history of allergic reactions to another therapeutic monoclonal antibody or biologic agent therapy, or any clear history of drug or food allergies, particularly those with allergies to similar components to the drug in this trial; 12 People who have received or are planning to receive live-reduced or active vaccines during the 30 days prior to randomization and the entire study period (including the follow-up period); 13 Smoking more than 5 cigarettes per day or using equivalent amounts of nicotine or nicotine-containing products during the 6 months prior to randomization and the entire study period (including the follow-up period); 14 People who had long-standing alcohol abuse or alcohol consumption of more than 14 units (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) of alcohol per week during the 3 months prior to screening and the entire study period (including the follow-up period), or those who tested positive for alcohol breath; 15 People with a history of substance abuse or positive urine drug screening; 16 Received any marketed or research biologics within 4 months or 5 half-lives (whichever is longer) prior to randomization; 17 Taking any prescription, over-the-counter and herbal medicines within 4 weeks prior to randomization, with the exception of vitamin products; 18 Use of any systemic cytotoxicity or systemic immunosuppressants within 6 months prior to randomization or during the study period, or any local cytotoxin or local immunosuppressive drug within 30 days or 5 half-life periods (whichever is longer) prior to randomization or during the study period; 19 Parasitic infection is associated and is excluded if any of the following are met: During the screening period, the stool routinely checks positive for eggs; History of parasitic infection within 6 months prior to the screening period; Have traveled or planned to travel to endemic parasitic infection areas (including but not limited to Southeast and South-West Asia, South America and Africa) within 6 months prior to screening visits; 20 Any situation in which the investigator believes that this poses a safety risk to the subject in the trial or may interfere with the conduct of the study, or that the investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Cao, Doctor
Phone
0532-82917310
Email
caoyu1767@126.com
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Cao, Doctor
Phone
0532-82917310
Email
caoyu1767@126.com

12. IPD Sharing Statement

Learn more about this trial

A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects

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