A Study of CL-197 Capsules in Healthy Participants

NCT05944848 | Completed Phase 1

• 1 other identifier: CR-CL-197-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV-1

Keywords

HIV-1; AIDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 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 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

Study Arms (5)

1mg group

EXPERIMENTAL

Single oral dose of 1 mg CL-197 capsules or CL-197 placebo

Drug: 1 mg CL-197 capsules

10mg group

EXPERIMENTAL

Single oral dose of 10 mg CL-197 capsules or CL-197 placebo

Drug: 10 mg CL-197 capsules or CL-197 placebo

30mg group

EXPERIMENTAL

Single oral dose of 30 mg CL-197 capsules or CL-197 placebo

Drug: 30 mg CL-197 capsules or CL-197 placebo

60mg group

EXPERIMENTAL

Single oral dose of 60 mg CL-197 capsules or CL-197 placebo

Drug: 60 mg CL-197 capsules or CL-197 placebo

100mg group

EXPERIMENTAL

Single oral dose of 100 mg CL-197 capsules or CL-197 placebo

Drug: 100 mg CL-197 capsules or CL-197 placebo

Interventions

1 mg CL-197 capsules DRUG

Single oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

1mg group

10 mg CL-197 capsules or CL-197 placebo DRUG

Single oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

10mg group

30 mg CL-197 capsules or CL-197 placebo DRUG

Single oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

30mg group

60 mg CL-197 capsules or CL-197 placebo DRUG

Single oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

60mg group

100 mg CL-197 capsules or CL-197 placebo DRUG

Single oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast

100mg group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects, aged 18\~45 (including boundary values), both male and female;
• 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;
• 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;
• Understand and sign the informed consent form voluntarily.

You may not qualify if:

• Allergic constitution, with a history of drug or food allergies, especially allergic to any ingredient in this product and excipients;
• Those with a history of hypoglycemia in the past;
• 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;
• Those with a history of smoking in the 12 months before screening (the number of cigarettes per day≥ 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;
• Those who have a history of drug abuse within 12 months before screening or who have tested positive for addictive substances before enrollment;
• 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;
• 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;
• 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;
• Those who have a febrile illness within 3 days before screening;
• Those who have participated in other clinical trials within 3 months before screening;
• 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;
• 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;
• Those who have lost blood or donated blood ≥ 200mL within 8 weeks before screening;
• Pregnant and lactating women;

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Wang Fusheng

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 13, 2023
• Study Start: November 16, 2022
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)