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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06085053
Other study ID # TQA3038-I-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 30, 2023
Est. completion date December 2025

Study information

Verified date October 2023
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Dong Liu, Doctor
Phone +86 13507183749
Email ld_2069@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics. In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Male or female age 18~60 years. - Body mass index (BMI) 19 - 26 kg/m^2. Exclusion Criteria: - Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; - History or evidence of drug or alcohol abuse; - History of intolerance to SC injection;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TQA3038 injection
TQA3038 is an injection.
TQA3038 injection matching placebo
Placebo injection contains no active substance.

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) and serious adverse events (SAEs) Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Up to 85 days.
Primary Number of subjects with clinically significant abnormalities Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. Up to 85 days.
Secondary Maximum Plasma Concentration (Cmax) Maximum concentration of TQA3038 and its metabolite in plasma Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Secondary Time to Reach Maximum Plasma Concentration (Tmax) Time to reach Cmax of TQA3038 and its metabolite in plasma Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Secondary Area Under the Plasma Concentration Versus Time Curve (AUC) Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Secondary Apparent Terminal Elimination Half-life (T1/2) Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Secondary Apparent Plasma Clearance (CL/F) Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
Secondary Fraction eliminated in the urine Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.
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