A Phase Ⅱa Clinical Study of CL-197 Capsules
ConditionHIV-1 Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHenan Genuine Biotech Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
CL-197 capsules
DrugParticipants 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: CL-197 capsulesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in log10 value of HIV-1 Ribonucleic acid (RNA) on Day 8
Time frame
Baseline and Day 8.Secondary outcomes
1
Change from baseline in log10 value of HIV-1 RNA on Day 11
Time frame
Baseline and Day 11.2
Change from baseline in CD4+ cell count on Day 13
Time frame
Baseline and Day 13.3
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).
Time frame
Day 13.4
Time to Maximum Concentration (Tmax) of CL -197
Time frame
Up to 13 days post-dose.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov