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

NCT06669429 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-11-01

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

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
2024-09-25
Primary Completion
2025-06-30
Completion
2025-08-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06669429 on ClinicalTrials.gov