Actively Recruiting
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects
Led by Peking University First Hospital · Updated on 2024-11-01
72
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Healthy adults aged 18 to 45 years
- Able to understand the study purpose and willing to sign informed consent
- Body mass index (BMI) between 19 and 26 kg/m2
- Male weight at least 50 kg; female weight at least 45 kg
- Overall good health confirmed by medical history, physical exam, vital signs, ECG, lab tests, and virus screening
- LDL cholesterol less than 4.1 mmol/L and triglycerides less than 3.4 mmol/L for multiple dose study participants
- Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for 6 months after last dose; male participants with partners of childbearing age must also agree to contraception use
You will not qualify if you...
- History of allergies or hypersensitivity to the investigational drug or its components
- Any current or past major diseases affecting neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, or skeletal systems
- Abnormal ECG readings (QTcF ≥450 ms for males, ≥470 ms for females)
- Estimated glomerular filtration rate (eGFR) below 80 mL/min/1.73m2
- History or current drug abuse within past 5 years or positive drug test
- Smoking more than 5 cigarettes daily or regular nicotine use within past 3 months, or inability to quit smoking during study
- Excessive alcohol use (more than 14 units weekly in past 3 months) or positive alcohol test at baseline
- Major surgery or clinically significant illness within 28 days before dosing
- Use of drugs or supplements affecting glucose or lipid metabolism within 30 days before dosing
- Consumption of caffeine or xanthine-containing foods or drinks within 48 hours before dosing
- Positive tests for HIV, hepatitis B or C, or syphilis
- Difficulty with blood draws or history of fainting with needles
- History of severe low blood sugar (grade 3 hypoglycemia)
- Participation in other clinical trials within past 3 months
- Blood donation or loss of more than 400 mL blood within past 3 months or planned donation during study
- Any other condition judged by investigator to make participation unsafe or unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
P
professor
CONTACT
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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