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Phase 2 Study of CL-197 Capsules in Adults with Untreated HIV-1 Infection Evaluating Safety, Drug Effects, and Dosage
Led by Henan Genuine Biotech Co., Ltd. · Updated on 2026-01-06
24
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the antiretroviral activity, safety, and how the body processes a single dose of CL-197 capsules in adults aged 18 to 60 with HIV-1 infection who have never received antiretroviral treatment. This Phase 2 clinical trial aims to explore the effects of different doses of CL-197 in treatment-naive patients, helping to understand its impact on the virus and immune cells. Participants will take one oral dose of CL-197 capsules at 10 mg, 30 mg, or 60 mg on an empty stomach. The study includes three dose groups to assess how the drug acts in the body and its safety. Follow-up includes measuring viral load and immune cell counts at specific days after dosing, with monitoring of drug levels in the blood over up to 13 days. During the trial, participants will undergo blood tests to measure changes in HIV-1 RNA levels and CD4 cells on days 8, 11, and 13. Safety will be checked by tracking any adverse events up to day 13. Blood samples will also be used to study how the drug is absorbed, distributed, and eliminated. The total participation period includes screening, dosing, and follow-up visits over about two weeks.
CONDITIONS
Brief Title
A Phase Ⅱa Clinical Study of CL-197 Capsules
Research Team
P
Ping DU
T
Tong Zhang
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