A Study of CL-197 Capsules in Healthy Participants

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of CL-197 Capsules Administered in Single Dose in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: HIV-1
• Intervention / Treatment: 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; Drug: 100 mg CL-197 capsules or CL-197 placebo; Drug: 1 mg CL-197 capsules

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li yuanyuan; Phone Number: +8618611839069; Email: lyy020818@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • The Fifth Medical Center of Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1mg group; Single oral dose of 1 mg CL-197 capsules or CL-197 placebo	Drug: 1 mg CL-197 capsules; Single oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 10mg group; Single oral dose of 10 mg CL-197 capsules or CL-197 placebo	Drug: 10 mg CL-197 capsules or CL-197 placebo; Single oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 30mg group; Single oral dose of 30 mg CL-197 capsules or CL-197 placebo	Drug: 30 mg CL-197 capsules or CL-197 placebo; Single oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 60mg group; Single oral dose of 60 mg CL-197 capsules or CL-197 placebo	Drug: 60 mg CL-197 capsules or CL-197 placebo; Single oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Experimental: 100mg group; Single oral dose of 100 mg CL-197 capsules or CL-197 placebo	Drug: 100 mg CL-197 capsules or CL-197 placebo; Single oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety and Tolerability of CL-197 Capsules ：Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria	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.	Up to 29 days post-dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HeNan Sincere Biotech Co., Ltd
• Investigators: Principal Investigator: Wang Fusheng, Medical Director

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIV-1; AIDS
• Other Study ID Numbers: CR-CL-197-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No