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RECRUITING
NCT06669429
PHASE1

A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects. This study will consist of two parts (Parts A and B). 42 subjects have been planned for Part A and 30 subjects for Part B.

Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of RS-C1001 Tablets in Chinese Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-09-25

Completion Date

2025-08-30

Last Updated

2024-11-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

RS-C1001

Subjects will receive RS-C1001 tablets orally as a single ascending dose

DRUG

RS-C1001

Subjects will receive RS-C1001 tablets orally as a multiple ascending dose

DRUG

RS-C1001

Subjects will receive RS-C1001 tablets orally as a single dose after intake of a high-calorie, high-fat breakfast

DRUG

placebo

Subjects will receive placebo matching tne RS-C1001 dose orally as a single ascending dose

DRUG

placebo

Subjects will receive placebo matching tne RS-C1001 dose orally as a multiple ascending dose

DRUG

Placebo

Subjects will receive placebo matching tne RS-C1001 dose orally as a single dose after intake of a high-calorie, high-fat breakfast

Locations (1)

Peking University First Hospital

Beijing, China