NCT07308782 A Phase Ⅱa Clinical Study of CL-197 Capsules
| NCT ID | NCT07308782 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Genuine Biotech Co., Ltd. |
| Condition | HIV-1 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-11-29 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
Eligibility Criteria
Inclusion Criteria: 1. Participants aged 18-60 (including boundary values), both male and female. 2. Body mass index (BMI) range between 18.5-29.9 (including the boundary value). Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women. 3. Participants diagnosed with HIV-1 infection before screening, and never received any anti-HIV drugs or HIV-related vaccine therapy (including investigational or other unmarketed anti-HIV drugs or vaccines) before screening. 4. Participants who agree not to receive other anti-HIV drugs during the trial period (from signing the informed consent form until the Day 13 sampling). 5. CD4 cell count \> 200 cells/μL at screening. 6. Women of childbearing potential (WOCBP) must have adopted effective non-drug contraceptive measures, have a negative serum pregnancy test at screening/baseline, and be willing to use appropriate effective methods of contraception from signing the informed consent form until 3 months after the last dose of the study drug. Male study
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