A Study of CL-197 Capsules in Healthy Participants

Phase 1

Completed

• Conditions: HIV-1
• Interventions: Drug: 100 mg CL-197 capsules or CL-197 placebo; Drug: 1 mg CL-197 capsules; Drug: 10 mg CL-197 capsules or CL-197 placebo; Drug: 30 mg CL-197 capsules or CL-197 placebo; Drug: 60 mg CL-197 capsules or CL-197 placebo

• Registration Number: NCT05944848
• Lead Sponsor: HeNan Sincere Biotech Co., Ltd

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions.

Detailed Description

In this trial, 46 healthy participants will be enrolled, 6 healthy participants in 1mg group, 40 healthy participants distributed equally in other four groups: 10mg group, 30mg group, 60mg group and 100mg group, including thier respective placebo control groups.

Study Timeline

• Study Start: 2022-11-16
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-13
• Primary Completion: 2024-01-20
• Study Completion: 2024-01-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Healthy adult subjects, aged 18~45 (including boundary values), both male and female;
2. Body mass index (BMI) should be in the range of 19.0-26.0 (including the boundary value) (BMI = weight (kg) / height 2 (m2)), the body weight of male subjects should be ≥ 50.0kg, and the body weight of female subjects should be ≥ 45.0kg;
3. Those who have no family plan within 2 weeks before screening and within 3 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial;
4. Understand and sign the informed consent form voluntarily.

Exclusion Criteria

1. Allergic constitution, with a history of drug or food allergies, especially allergic to any ingredient in this product and excipients;
2. Those with a history of hypoglycemia in the past;
3. Pre-test medical history, physical examination, laboratory items and test-related examinations and abnormal tests have clinical significance, and the clinical research doctor judges to be unqualified;
4. Those with a history of smoking in the 12 months before screening (the number of cigarettes per day≥ 5);
5. Those who have a history of alcoholism in the 12 months before screening (drink ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value>0mg/100mL) before enrollment;
6. Those who have a history of drug abuse within 12 months before screening or who have tested positive for addictive substances before enrollment;
7. Those who have undergone surgery within 3 months before screening, especially those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion, or those who plan to undergo surgery during the study;
8. Any drugs that interact with investigational drugs, such as potent CYP3A inhibitors (such as clarithromycin, indinavir, itraconazole, etc.), have been used within 30 days before screening;
9. Have a previous history of cardiovascular, hepatic, renal, lung, digestive tract, nerve and other diseases, especially any surgical condition or condition that may affect the absorption, distribution, metabolism and excretion of drugs, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial;
10. Those who have a febrile illness within 3 days before screening;
11. Those who have participated in other clinical trials within 3 months before screening;
12. Those who have a history of taking any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health products within 14 days before screening;
13. Those who consumed excessive tea, coffee and/or beverages rich in caffeine, xanthine and alcohol (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening;
14. Those who have lost blood or donated blood ≥ 200mL within 8 weeks before screening;
15. Pregnant and lactating women;
16. Those who cannot tolerate venipuncture blood collection and/or have a history of blood sickness and needle sickness;
17. Those who have been vaccinated against the new coronavirus within 1 week before screening, or those who have received other vaccines within 3 months before screening;
18. Those who are not considered suitable to enter this test by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
100mg group	100 mg CL-197 capsules or CL-197 placebo	Single oral dose of 100 mg CL-197 capsules or CL-197 placebo
1mg group	1 mg CL-197 capsules	Single oral dose of 1 mg CL-197 capsules or CL-197 placebo
10mg group	10 mg CL-197 capsules or CL-197 placebo	Single oral dose of 10 mg CL-197 capsules or CL-197 placebo
30mg group	30 mg CL-197 capsules or CL-197 placebo	Single oral dose of 30 mg CL-197 capsules or CL-197 placebo
60mg group	60 mg CL-197 capsules or CL-197 placebo	Single oral dose of 60 mg CL-197 capsules or CL-197 placebo

Primary Outcome Measures

Name	Time	Method
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria	Up to 29 days post-dose	The degree of adverse events observed in the trial would be determined by the NCI CTCAE v5.0 grading criteria, and the adverse events related to the test drug (definitely related, likely to be related, and possibly related) would be terminated in the following cases, and the previous dose would be used as the MTD of the single-dose tolerance test.

Secondary Outcome Measures

Name	Time	Method
The Peak Plasma Concentration (Cmax) of CL-197 Capsules	Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups	The index components in human blood samples would be measured by LC-MS/MS, and the peak plasma concentration (Cmax) would be calculated.
The Area Under the Plasma Concentration Versus Time Curve (AUC) of CL-197 Capsules	Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups	The index components in human blood samples would be measured by LC-MS/MS, and the area under the plasma concentration versus time curve (AUC) would be calculated.
The Elimination Half-Life (t1/2) of CL-197 Capsules	Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups	The index components in human blood samples would be measured by LC-MS/MS, and the elimination half-life (t1/2) would be calculated.
The Accumulate Urinary Drug Excretion (Ae) of CL-197 Capsules	Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups	The index components in human urine samples would be measured by LC-MS/MS, and the accumulate urinary drug excretion (Ae) would be calculated.

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China