A Phase 1 interventional study of RS-C1001 and RS-C1001 in Dyslipidemia, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Peking University First Hospital · Phase 1, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's planned enrollment of 72 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RS-C1001
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: placebo
Drug: RS-C1001 · Drug: Placebo
Subjects will receive RS-C1001 tablets orally as a single ascending dose
Subjects will receive RS-C1001 tablets orally as a multiple ascending dose
Subjects will receive RS-C1001 tablets orally as a single dose after intake of a high-calorie, high-fat breakfast
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
Numbers 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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Peking University First Hospital