RecruitingPhase 2NCT07308782

A Phase Ⅱa Clinical Study of CL-197 Capsules

An Exploratory Pharmacodynamic Clinical Study of CL-197 Capsules in Treatment Naive Patients With Human Immunodeficiency Virus (HIV-1)


Sponsor

Henan Genuine Biotech Co., Ltd.

Enrollment

24 participants

Start Date

Nov 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This early-stage clinical trial tests a new antiretroviral drug called CL-197 in adults who have been recently diagnosed with HIV-1 infection and have never taken any HIV medication before, to evaluate its safety and how the body processes it. **You may be eligible if...** - You are between 18 and 60 years old - You have a BMI between 18.5 and 29.9 (and weigh at least 50 kg if male, or 45 kg if female) - You have been diagnosed with HIV-1 infection prior to screening - You have never taken any anti-HIV drugs or HIV vaccines before - You agree not to take other anti-HIV drugs during the trial **You may NOT be eligible if...** - You have previously received any HIV treatment or related vaccines - Your BMI or weight falls outside the required range - You have other significant health conditions your doctor would assess Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCL-197 capsules

Participants will take a single dose of CL-197 capsules at a dose of 10 mg, 30 mg or 60 mg, orally on an empty stomach.


Locations(1)

Beijing Youan Hospital, Capital Medical University

Beijing, China

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NCT07308782


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