RecruitingPhase 1NCT06669429

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

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


Sponsor

Peking University First Hospital

Enrollment

72 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called RS-C1001, and others for people with dyslipidemia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRS-C1001

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

DRUGRS-C1001

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

DRUGRS-C1001

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

DRUGplacebo

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

DRUGplacebo

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

DRUGPlacebo

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

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NCT06669429


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