Testing TQA3038 Injection in Healthy Adults
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.
PHASE1 · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT06085053
This study is testing a new injection called TQA3038 in healthy adults to see if it's safe and how it works in the body, which could help treat chronic hepatitis B.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06085053 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety and tolerability of TQA3038 injection in healthy adult subjects. Participants will receive either TQA3038 or a placebo through a single ascending dose administered subcutaneously. The study aims to assess pharmacokinetics and monitor any adverse effects following the injection. The focus is on understanding how the drug behaves in the body and its potential implications for treating chronic hepatitis B.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 60 with a BMI between 19 and 26 kg/m².
Not a fit: Patients with significant chronic or acute medical conditions or a history of drug or alcohol abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for chronic hepatitis B.
How similar studies have performed: While this approach is novel in the context of TQA3038, similar studies assessing safety and pharmacokinetics of new drugs have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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；
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Dong Liu, Doctor
- Email: ld_2069@163.com
- Phone: +86 13507183749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Hepatitis b