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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Peking University First Hospital
Beijing, China
RECRUITINGNumbers of participants with Adverse Events (AEs) or Serious Adverse Events(SAEs).
Incidence, type, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 after single and multiple oral administration of RS-C1001 tablets in healthy male and female participants.
Time frame: Part A1 (SAD): Day1-7; Part A2 (FE): Day1-14; Part B (MAD): Day1-16
Numbers of participants with clinical laboratory tests abnormalities
Safety blood and urine samples collected are assessed for lab values that move out of the normal range will be noted and assessed for clinical significance. Any clinically significant abnormality, including changes from baseline, must be reported as an AE.
Time frame: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Numbers of participants with vital sign abnormalities
Numbers of participants with vital sign abnormalities
Time frame: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
Numbers of participants with physical examination abnormalities
Numbers of participants with physical examination abnormalities
Time frame: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Number of participants with 12-lead electrocardiogram(ECG) abnormalities
Number of participants with 12-lead ECG abnormalities including PR, RR, QRS, QT and QTcF.
Time frame: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
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Subjects will receive placebo matching tne RS-C1001 dose orally as a single ascending dose
Subjects will receive placebo matching tne RS-C1001 dose orally as a multiple ascending dose
Subjects will receive placebo matching tne RS-C1001 dose orally as a single dose after intake of a high-calorie, high-fat breakfast