A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects

Inclusion Criteria:

1. Subjects should fully understand the purpose, nature, method and possible adversereactions of the test, and voluntarily sign the informed consent.

2. Healthy subjects aged 18-45 years old (including boundary values, subject to thetime 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 ofmales 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 basedon their medical history, physical examination, vital signs, 12 leadelectrocardiogram , laboratory tests (blood routine, urine routine, bloodbiochemistry, coagulation function, early kidney damage detection), virus serology,and other results (normal or abnormal examination results have no clinicalsignificance);

5. The serum LDL-C of the enrolled subjects in MAD study is less than 4.1 mmol/L, andthe serum TG is less than 3.4 mmol/L.

6. Female participants must be in a negative pregnant and non lactating state; Andfemale subjects of childbearing age and male subjects with female partners ofchildbearing age agree to use contraception from the screening period until 6 monthsafter 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 allergicto the investigational drug or any component of the investigational drug asdetermined by the researcher;

2. Subjects with abnormal clinical manifestations, including but not limited toneurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory,metabolic, endocrine, immune, and skeletal system diseases, who have been evaluatedby the researchers as unsuitable for participation in this study;

3. Screening and baseline 12 lead electrocardiogram results (adjusted by Fridericiaformula, 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 ≥ 470ms;

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 useddrugs in the three months prior to screening, or who tested positive for drug abuseduring screening or baseline;

6. Individuals who have smoked more than 5 cigarettes per day or habitually usednicotine containing products within the previous 3 months, or who are unable to quitsmoking during the trial period;

7. Individuals who have consumed more than 14 units of alcohol per week within theprevious 3 months (1 unit of alcohol=360 mL of beer, 45 mL of spirits with analcohol 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 alcoholbreath test at baseline;

8. Those who have suffered from clinically significant major diseases or undergonemajor surgical procedures within 28 days prior to receiving the investigationaldrug, 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 beforereceiving the investigational drug, and the time interval between the start of thedrug administration and the start of the trial is greater than 5 half lives, thecorresponding subjects can also be enrolled; Within 30 days before accepting theinvestigational drug, use any known Chinese herbal medicine, vitamin, or tonic thatcan affect glucose and lipid metabolism (such as fish oil>1000 mg/day, drugs orhealth supplements containing Monascus rice ingredients);

10. Those who consume any food or beverage containing or metabolized to produce caffeineor xanthine (such as coffee, tea, chocolate) within 48 hours prior to receiving theinvestigational drug;

11. Screening period virus serological testing for subjects who are positive for humanimmunodeficiency virus antibodies (HIV Ab), HBV surface antigen (HBsAg), HCVantibodies (HCV Ab), or Treponema pallidum antibodies (TP Ab);

12. Those who have difficulty in venous blood collection or have a history of needle andblood dizziness;

13. Subjects with a history of grade 3 hypoglycemia;

14. Subjects who have used other clinical trial drugs or participated in clinical trialsof medical devices within the past 3 months prior to receiving the investigationaldrug;

15. Subjects who have a history of blood donation or have lost more than 400 mL of bloodin the three months prior to screening, or who plan to donate blood during the trialperiod;

16. The researcher believes that the participant is not suitable to participate in thetrial due to other reasons or withdraws from the trial due to personal reasons.