A Study of CL-197 Capsules in Healthy Participants

NCT05944848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-04-25

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wang Fusheng · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-01-20
Completion
2024-01-20

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05944848 on ClinicalTrials.gov