NCT06669429

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, First In Human (FIH), randomized, double-blind, placebo-controlled study in Chinese healthy subjects. 42 subjects have been planned for Part A and 30 subjects for Part B. Part A: A Screening Period of maximum 14 days. Admission to study center (Day -1). A Treatment Period (Day 1 to Day 4) with a single dose of RS-C1001 or placebo on Day 1. Subjects will be discharged on Day 4. A Follow-up Visit within 6 to 8 days after the Investigational Medicinal Product (IMP) dose for all cohorts. (i) Part A1 - Up to 6 dose cohorts of RS-C1001 are planned to be investigated. Two subjects (one male and one female) planned to be enrolled in the 50 mg dose cohort will receive the investigational drug orally. The remaining 5 dose cohorts, 6 subjects will be randomized to receive RS-C1001, and 2 subjects randomized to receive placebo. (ii) Part A2 - The subjects from a chosen cohort in Part A1 will return to the study center no sooner than 7 days after the first dose administration of IMP and will receive RS-C1001 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of RS-C1001. The subjects will stay at the study center until 72 hours post-dose in both the parts. • Part B: Multiple Ascending Dose (MAD) cohort - Up to 3 dose cohorts are planned to be investigated. In each cohort, 10 subjects will participate and receive either RS-C1001 or placebo, randomized 4:1 for 10 days dosing. Subjects will be discharged on Day 13. A Follow-up Visit within 15 to 17 days after the Investigational Medicinal Product (IMP) dose for all cohorts.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-06-30
• Completion: 2025-08-30
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: China