A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

Chronic Hepatitis b Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085053
• Other study ID #: TQA3038-I-01
• Status: Recruiting
• Phase: Phase 1
• 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
• 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;

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic

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.