Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
ID07308782

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

Led by Henan Genuine Biotech Co., Ltd. · Updated on 2026-01-06

24

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18-60 years, male or female
  • Body mass index (BMI) between 18.5 and 29.9
  • Body weight ≥ 50 kg for men and ≥ 45 kg for women
  • Diagnosed with HIV-1 infection before screening
  • Never received any anti-HIV drugs or HIV-related vaccine therapy before screening
  • Agree not to use other anti-HIV drugs during the trial period
  • CD4 cell count greater than 200 cells/µL at screening
  • Women of childbearing potential must use effective non-drug contraception and have a negative pregnancy test
  • Male participants must agree to use effective contraception or be surgically sterilized
  • Able to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Acute HIV-1 infection or AIDS-defining disease at enrollment
  • Opportunistic infection within 3 months prior to enrollment that is unstable
  • Use of PrEP or PEP within 1 month prior to screening
  • Poorly controlled significant diseases including cardiovascular, respiratory, digestive, endocrine/metabolic, neurological/psychiatric, hematological, or immune system disorders
  • High resting blood pressure (≥140/90 mmHg) or abnormal heart rate (<50 or >100 bpm)
  • QTcF interval > 450 ms or fasting blood glucose ≥ 7.0 mmol/L
  • History of severe drug or food allergy requiring medication control
  • Major gastrointestinal surgery within 6 months prior to screening or planned surgery during the trial
  • History of malignancy except certain skin or cervical carcinomas
  • Positive for Hepatitis B surface antigen, active syphilis, or Hepatitis C antibody
  • Low blood counts or abnormal liver/kidney function tests
  • Smoking more than 5 cigarettes daily within 3 months prior to screening
  • Excessive alcohol or caffeine consumption or unwillingness to stop during hospitalization
  • Consumption of certain foods or special diets that affect drug metabolism within 48 hours prior to dosing
  • History of drug abuse within 5 years prior to screening
  • Intolerance to blood draws or recent significant blood loss or transfusion
  • Specific dietary requirements that conflict with standardized diet
  • Participation in other investigational drug or device trials within 3 months prior to screening
  • Pregnant or breastfeeding females, or positive pregnancy test
  • Plans for pregnancy or sperm/egg donation during and after the study period
  • Use of any prescription, over-the-counter, or herbal medicines within 14 days prior to dosing
  • Any other condition the investigator considers unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 13 days post-dose

Participants take a single dose of CL-197 capsules orally on an empty stomach at one of three dosage levels (10 mg, 30 mg, or 60 mg).

Baseline visit and follow-up visits on Days 8, 11, and 13

Trial Site Locations

Total: 1 location

1

Beijing Youan Hospital, Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

P

Ping DU

T

Tong Zhang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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