A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Phase 1

Recruiting

• Conditions: Chronic Hepatitis b
• Interventions: Drug: TQA3038 injection; Drug: TQA3038 injection matching placebo

• Registration Number: NCT06085053
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-16
• Study Start: 2023-11-30
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQA3038 injection	TQA3038 injection	One dose of TQA3038 injection in Day 1.
TQA3038 injection matching placebo	TQA3038 injection matching placebo	One dose of TQA3038 injection matching placebo in Day 1.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Up to 85 days.	Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of subjects with clinically significant abnormalities	Up to 85 days.	Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose	Maximum concentration of TQA3038 and its metabolite in plasma
Area Under the Plasma Concentration Versus Time Curve (AUC)	Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose	Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time
Apparent Terminal Elimination Half-life (T1/2)	Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose	Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma
Time to Reach Maximum Plasma Concentration (Tmax)	Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose	Time to reach Cmax of TQA3038 and its metabolite in plasma
Apparent Plasma Clearance (CL/F)	Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose	Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma
Fraction eliminated in the urine	Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.	Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China