HIV-1 InfectionPhase 2NCT07308782
A Phase Ⅱa Clinical Study of CL-197 Capsules
A Phase 2 study testing CL-197 capsules in people with HIV-1 Infection, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- CL-197 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged 18-60 (including boundary values), both male and female.
- 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.
- 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.
- 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).
- CD4 cell count > 200 cells/μL at screening.
- 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 participants must be willing to refrain from fathering children and voluntarily use effective contraception during the trial and until 3 months after the last dose of the study drug, or have been surgically sterilized.
- Participants who understand and sign the informed consent form.
Who cannot join
- Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months prior to enrollment with the condition remaining unstable within 4 weeks prior to enrollment.
- Had pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.
- Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine/metabolic, neurological/psychiatric, hematological, and immune system diseases, etc.) that is poorly controlled, as determined by the investigator at screening.
- Resting systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, or heart rate > 100 beats per minute, or heart rate < 50 beats per minute, or QTcF (QT interval corrected for heart rate according to Fridericia's formula) > 450 ms, or fasting blood glucose ≥ 7.0 mmol/L.
- History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug components (e.g., lactose or gelatin), or food, or history of allergic diseases requiring medication control (e.g., asthma, urticaria, atopic dermatitis/eczema, etc.) prior to screening.
- Had major gastrointestinal surgery within 6 months prior to screening (except uncomplicated appendectomy or cholecystectomy), or any surgery that could affect drug absorption, distribution, metabolism and excretion; or planned elective surgery during the trial period, as determined by the investigator at screening.
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- History of malignancy (except carcinoma in situ of the cervix treated with conization, or radically resected basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [Bowen's disease] of the skin).
- Hepatitis B surface antigen (HBsAg) positive at screening, or active syphilis, or Hepatitis C virus (HCV) antibody positive, or previous interferon treatment for HBV infection leading to HBsAg seroconversion.
- Hemoglobin (Hb) < 110 g/L, or white blood cell (WBC) count < 3 × 10^9/L, or absolute neutrophil count (ANC) < 1 × 10^9/L, or platelet (PLT) count < 100 × 10^9/L at screening.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 times upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.5 × ULN at screening.
- Serum creatinine (SCr) > 1.1 × ULN, or creatinine clearance (Ccr) < 60 mL/min (calculated by Cockcroft-Gault formula) at screening.
- Participants smoke more than 5 cigarettes daily on average within 3 months prior to screening, or may be unwilling to stop using any tobacco products during drug administration and sampling periods.
- Drinking more than 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer with 5% alcohol, or 45 mL of liquor with 40% alcohol, or 150 mL of wine with 12% alcohol) within 3 months prior to screening on average, or positive alcohol breath test at screening or baseline, or unwillingness to stop using any alcohol-containing products during hospitalization.
- Excessive consumption of tea, coffee, and/or caffeine-containing beverages (averaging more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to screening on average, or unwillingness to stop consuming tea, coffee, and/or caffeine-containing beverages during hospitalization.
- Participants with consumption of pitaya, mango, pomelo, carambola, or foods/beverages prepared from them, or foods/beverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or any other special diet that may affect drug absorption, distribution, metabolism, or excretion within 48 hours prior to the first dose of the investigational product, or unwillingness to stop using them during hospitalization.
- History of drug abuse (non-medical, excessive, misuse, or addictive use of any drug leading to social, psychological, or physical impairment) within 5 years prior to screening, or positive urine drug screen at screening or baseline.
- Intolerance to venipuncture, or history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or blood transfusion within 3 months prior to screening, or blood donation plan during the trial.
- Specific dietary requirements during the trial, or inability to accept the standardized diet.
- Have participated in or are participating in other investigational drug or interventional medical device clinical trials (having signed informed consent and received investigational drug/interventional device or placebo) within 3 months prior to screening.
- Pregnant or breastfeeding females at screening, or positive serum pregnancy test (applicable to WOCBP only).
- Have a birth plan (including egg or sperm donation) by WOCBP or male participants from 1 month prior to informed consent until 3 months after administration of the investigational drug, or unwillingness to use effective contraception/barrier methods (including one or more non-drug contraceptive methods or abstinence from heterosexual activity).
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within 14 days prior to dosing.
- Any other conditions considered by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing
About this study
Official title: An Exploratory Pharmacodynamic Clinical Study of CL-197 Capsules in Treatment Naive Patients With Human Immunodeficiency Virus (HIV-1)
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.
- Conditions
- HIV-1 Infection
- Being tested
- CL-197 capsules
- Keywords
- HIV-1 infection, CL-197
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL-197 capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CL-197 capsules | Experimental | Not described Receives: Drug: CL-197 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in log10 value of HIV-1 Ribonucleic acid (RNA) on Day 8
Measured: Baseline and Day 8.
Secondary outcomes (7)
Change from baseline in log10 value of HIV-1 RNA on Day 11
Measured: Baseline and Day 11.
Change from baseline in CD4+ cell count on Day 13
Measured: Baseline and Day 13.
Incidence of adverse events (AEs) / serious AEs
AEs are assessed based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table).
Measured: Day 13.
Time to Maximum Concentration (Tmax) of CL -197
Measured: Up to 13 days post-dose.
Elimination Half-Life (t1/2) of CL -197
Measured: Up to 13 days post-dose.
Maximum Observed Plasma Concentration (Cmax) of CL -197
Measured: Up to 13 days post-dose.
Area Under the Concentration-time Curve (AUC) of CL -197
Measured: Up to 13 days post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start29 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308782
- Sponsor's protocol ID
- GB-CL-197-102
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pharmacodynamic Clinical Study of CL-197 Capsules in Treatment Naive Patients With Human Immunodeficiency Virus (HIV-1)
- ClinicalTrials.gov ID
- NCT07308782
- Acronym / sponsor ID
- GB-CL-197-102
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1 infection, CL-197
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL-197 capsules | Experimental | Drug: CL-197 capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants aged 18-60 (including boundary values), both male and female.
- 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.
- 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.
- 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).
- CD4 cell count > 200 cells/μL at screening.
Key exclusion criteria (23 listed)
- Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months prior to enrollment with the condition remaining unstable within 4 weeks prior to enrollment.
- Had pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.
- Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine/metabolic, neurological/psychiatric, hematological, and immune system diseases, etc.) that is poorly controlled, as determined by the investigator at screening.
- Resting systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, or heart rate > 100 beats per minute, or heart rate < 50 beats per minute, or QTcF (QT interval corrected for heart rate according to Fridericia's formula) > 450 ms, or fasting blood glucose ≥ 7.0 mmol/L.
- History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug components (e.g., lactose or gelatin), or food, or history of allergic diseases requiring medication control (e.g., asthma, urticaria, atopic dermatitis/eczema, etc.) prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL-197 capsulesParticipants 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. | Drug | CL-197 capsules |
Primary outcome
Change from baseline in log10 value of HIV-1 Ribonucleic acid (RNA) on Day 8
Time frame: Baseline and Day 8.
7 secondary outcomes
Change from baseline in log10 value of HIV-1 RNA on Day 11
Time frame: Baseline and Day 11.
Change from baseline in CD4+ cell count on Day 13
Time frame: Baseline and Day 13.
Incidence of adverse events (AEs) / serious AEs
Time frame: Day 13.
Time to Maximum Concentration (Tmax) of CL -197
Time frame: Up to 13 days post-dose.
Elimination Half-Life (t1/2) of CL -197
Time frame: Up to 13 days post-dose.
Maximum Observed Plasma Concentration (Cmax) of CL -197
Time frame: Up to 13 days post-dose.
Area Under the Concentration-time Curve (AUC) of CL -197
Time frame: Up to 13 days post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CL-197 capsules in people with HIV-1 Infection, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping DU (8618810261827, pingdu2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in log10 value of HIV-1 Ribonucleic acid (RNA) on Day 8 (time frame: Baseline and Day 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.