Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of RS-C1001 Tablets in Healthy Chinese Adults
Led by Peking University First Hospital · Updated on 2024-11-01
72
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of food on RS-C1001 tablets in healthy Chinese adults aged 18 to 45 years. This Phase I, first-in-human, randomized, double-blind, placebo-controlled study aims to understand how RS-C1001 behaves in the body and its safety profile. The study is divided into two parts, including single and multiple dose assessments.
CONDITIONS
Brief Title
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must understand the study and voluntarily sign informed consent
- Healthy adults aged 18 to 45 years, any gender
- BMI between 19 and 26 kg/m2; males weigh at least 50 kg, females at least 45 kg
- Overall good health based on medical history, physical exam, vital signs, ECG, lab tests, and virus serology
- For multiple dose study: LDL-C less than 4.1 mmol/L and triglycerides less than 3.4 mmol/L
- Females must be not pregnant or lactating; both females of childbearing potential and male partners agree to use contraception during and 6 months after study
You will not qualify if you...
- History of drug or other allergies or allergy to study drug components
- Abnormal clinical conditions affecting major body systems deemed unsuitable by researchers
- ECG QTcF values ≥450 ms for males or ≥470 ms for females
- Estimated glomerular filtration rate (eGFR) below 80 mL/min/1.73m²
- History or recent drug abuse or positive drug tests
- Smoking more than 5 cigarettes per day or nicotine use within 3 months
- Alcohol consumption above defined limits or positive alcohol breath test
- Major diseases or surgeries within 28 days before dosing
- Use of certain drugs, herbal medicines, or supplements affecting metabolism within specified periods
- Consumption of caffeine or xanthine-containing products within 48 hours before dosing
- Positive serology for HIV, HBV, HCV, or syphilis
- History of difficulty with blood draws or severe hypoglycemia
- Participation in other clinical trials or blood donation within 3 months
- Other reasons making the participant unsuitable as judged by the researcher or personal withdrawal from the trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 14 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Part A: 4 days; Part B: 13 days
Participants receive RS-C1001 or placebo tablets orally. Part A involves a single dose with a stay at the study center from Day 1 to Day 4. Part B involves multiple ascending doses daily for 10 days with discharge on Day 13.
Admission on Day -1; daily visits during dosing period; discharge on Day 4 (Part A) or Day 13 (Part B)
Duration - 6 to 8 days after dosing for Part A; 15 to 17 days after dosing for Part B
Participants attend a follow-up visit to monitor safety and tolerability after dosing is completed.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
P
professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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