A Phase I Study to Evaluate the Effect of Food on the Pharmacokinetics of HS-10382 Tablets in Healthy Participants

Inclusion Criteria:

1. Signed informed consent before the trial, with full understanding of the trial content, procedures, and possible adverse reactions, and self-reported ability to complete the study according to the study requirements;
2. Adult males and females (age ≥18 years, calculated as of the day of signing the informed consent form);
3. Participant body mass index (BMI) = weight (kg)/height² (m²), with BMI within the range of 19.0-26.0 kg/m² (inclusive). Male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg;
4. Agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of HS-10382, and have no plans for conception or sperm/egg donation during this period.

Exclusion Criteria:

1. Have clinically significant abnormalities, as judged by the investigator, in physical examination, vital signs, 12-lead ECG, clinical laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function), abdominal ultrasound, etc. during the screening period;
2. Have a history of hepatitis B, hepatitis C, HIV, or syphilis, and/or any one or more clinically significant abnormalities in the four infectious disease screening tests;
3. Have a history of, or current, severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system, urinary system, etc., or have new-onset disease before use of the investigational drug, which the investigator considers unsuitable for participation in this study;
4. Have gastrointestinal dysfunction, dysphagia, or a history of surgery affecting drug absorption, distribution, metabolism, or excretion, which the investigator judges unsuitable for enrollment;
5. Have susceptibility to allergic reactions or an allergic constitution (e.g., allergy to pollen, or to two or more drugs/foods), or have a known allergy to the investigational drug or any of its components;
6. Have participated in any other clinical trial and used investigational drugs or devices within 3 months before the first dose;
7. Have donated blood and/or lost more than 200 mL of blood (excluding menstrual blood loss in females) within 3 months before the first dose, and/or received a blood transfusion or blood products, or have plans to donate blood during the study;
8. Have had excessive intake of tea, coffee, and/or caffeine-containing beverages within 3 months before screening (more than 8 cups per day on average, 1 cup = 200 mL), or be unable to stop intake of tea, coffee, and/or caffeine-containing beverages during the study;
9. Have ingested grapefruit or grapefruit products within 48 h before the first dose, or be unable to stop intake of grapefruit or grapefruit products during the study;
10. Have had regular alcohol consumption within 3 months before screening (i.e., more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer, 45 mL liquor with 40% alcohol, or 150 mL wine; equivalent to 10 bottles of beer, 1 jin of baijiu, or 3 bottles of red wine per week), or have a positive blood alcohol test, or be unable to stop consumption of alcoholic products during the study;
11. Have smoked more than 5 cigarettes per day on average within 3 months before screening, or be unable to stop use of any tobacco products during the study;
12. Have a history of drug abuse or drug dependence, or have used illicit drugs within 5 years before screening, or have a positive urine drug abuse screening result;
13. Have used any drug that may affect P-gp, BCRP, and/or CYP 2B6 or 3A enzyme activity within 30 days or 5 half-lives of the drug (whichever is longer) before the first dose;
14. Have used any prescription drug, over-the-counter drug, herbal medicine, or health product (except topical preparations with local action) within 14 days before the first dose;
15. Be unable to tolerate venipuncture/indwelling needle blood collection, or have a history of needle or blood phobia;
16. Be breastfeeding within 1 month before screening or during the study, or have a positive pregnancy test result during the screening period (for female participants of childbearing potential);
17. Be likely unable to complete this study for other reasons, or be judged unsuitable for participation by the investigator.