Assessing the safety and effects of RS-C1001 tablets in healthy Chinese adults

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

This study is testing how safe and effective RS-C1001 tablets are in healthy Chinese adults by giving them either the drug or a placebo and monitoring their reactions.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06669429 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of RS-C1001 tablets in healthy Chinese subjects. The study is divided into two parts: Part A involves a single dose administration of RS-C1001 or placebo, while Part B focuses on multiple ascending doses over a 10-day period. Participants will be monitored for adverse reactions and the effects of food on the drug's pharmacokinetics. The trial aims to gather essential data on the investigational drug's profile in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates are healthy Chinese adults aged 18-45 with a BMI between 19 and 26 kg/m2.

Not a fit: Patients with existing dyslipidemia or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of RS-C1001 for managing dyslipidemia.

How similar studies have performed: Other studies on similar pharmacological approaches have shown promise, but this specific investigation is novel.

Eligibility criteria

Inclusion Criteria:

1. Subjects should fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily sign the informed consent.
2. Healthy subjects aged 18-45 years old (including boundary values, subject to the time of signing the informed consent form), regardless of gender;
3. Have a BMI between 19 and 26 kg/m2 (including the boundary value), and the weight of males is not less than 50 kg, and the weight of females is not less than 45 kg;
4. Researchers determine that the overall health status of the subjects is good based on their medical history, physical examination, vital signs, 12 lead electrocardiogram , laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, early kidney damage detection), virus serology, and other results (normal or abnormal examination results have no clinical significance);
5. The serum LDL-C of the enrolled subjects in MAD study is less than 4.1 mmol/L, and the serum TG is less than 3.4 mmol/L.
6. Female participants must be in a negative pregnant and non lactating state; And female subjects of childbearing age and male subjects with female partners of childbearing age agree to use contraception from the screening period until 6 months after the last dose (using medically recognized effective contraceptive measures). Male subjects can only donate sperm 6 months after the last dose.

Exclusion Criteria:

1. Individuals with a history of drug or other allergies, or those who may be allergic to the investigational drug or any component of the investigational drug as determined by the researcher;
2. Subjects with abnormal clinical manifestations, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal system diseases, who have been evaluated by the researchers as unsuitable for participation in this study;
3. Screening and baseline 12 lead electrocardiogram results (adjusted by Fridericia formula, QTcF=QT/(RR \^ 0.33), where RR=60/heart rate) for male subjects with QTcF (average of 3 consecutive test results) ≥ 450 ms and female subjects with QTcF ≥ 470 ms;
4. Subjects with eGFR\<80 mL/min/1.73m ²;
5. Individuals who have a history of drug abuse within the past five years or have used drugs in the three months prior to screening, or who tested positive for drug abuse during screening or baseline;
6. Individuals who have smoked more than 5 cigarettes per day or habitually used nicotine containing products within the previous 3 months, or who are unable to quit smoking during the trial period;
7. Individuals who have consumed more than 14 units of alcohol per week within the previous 3 months (1 unit of alcohol=360 mL of beer, 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or have taken alcoholic products within 48 hours prior to receiving the test drug, or have tested positive for alcohol breath test at baseline;
8. Those who have suffered from clinically significant major diseases or undergone major surgical procedures within 28 days prior to receiving the investigational drug, or who are expected to undergo major surgery during the trial period;
9. If the researcher determines that any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements have been used within 14 days before receiving the investigational drug, and the time interval between the start of the drug administration and the start of the trial is greater than 5 half lives, the corresponding subjects can also be enrolled; Within 30 days before accepting the investigational drug, use any known Chinese herbal medicine, vitamin, or tonic that can affect glucose and lipid metabolism (such as fish oil\>1000 mg/day, drugs or health supplements containing Monascus rice ingredients);
10. Those who consume any food or beverage containing or metabolized to produce caffeine or xanthine (such as coffee, tea, chocolate) within 48 hours prior to receiving the investigational drug;
11. Screening period virus serological testing for subjects who are positive for human immunodeficiency virus antibodies (HIV Ab), HBV surface antigen (HBsAg), HCV antibodies (HCV Ab), or Treponema pallidum antibodies (TP Ab);
12. Those who have difficulty in venous blood collection or have a history of needle and blood dizziness;
13. Subjects with a history of grade 3 hypoglycemia;
14. Subjects who have used other clinical trial drugs or participated in clinical trials of medical devices within the past 3 months prior to receiving the investigational drug;
15. Subjects who have a history of blood donation or have lost more than 400 mL of blood in the three months prior to screening, or who plan to donate blood during the trial period;
16. The researcher believes that the participant is not suitable to participate in the trial due to other reasons or withdraws from the trial due to personal reasons.

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: professor

Conditions Dyslipidemia; RS-C1001 tablets Dyslipidemia