NCT05944848

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV-1

Interventions

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

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-01-20
• Completion: 2024-01-20
• First posted: 2023-07-13
• Last updated: 2024-04-25

Locations

1 site across 1 country: China