Comparison of HBW-3220 Capsule Formulations and the Effect of Food in Healthy Participants

Inclusion Criteria:

1. The participant has provided written informed consent before any study-related activity, fully understands the purpose and significance of the study, and is willing to comply with the study protocol.
2. Aged 18 to 55 years, inclusive.
3. Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg. Body mass index (BMI) must be between 19.0 and 26.0 kg/m2, inclusive.
4. Able to tolerate a high-fat meal.
5. No unprotected sexual intercourse within 2 weeks before screening. Participants must have no plans for conception and must agree to use effective contraceptive measures from screening until 3 months after the last dose of the study drug.

Exclusion Criteria:

1. History or current presence of any clinically significant disease involving the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematologic, immune, psychiatric, or metabolic systems, or any other disease that may interfere with the study results, including but not limited to deep vein thrombosis, pulmonary embolism, bleeding disorders, or poorly controlled infection.
2. History of allergy to drugs, food, or other substances, or known hypersensitivity to any component or excipient of HBW-3220 capsules.
3. Unable to tolerate venipuncture, difficult venous access, or a history of fainting during needle insertion or blood collection.
4. Surgery within 3 months before the study or planned surgery during the study.
5. Use of any medication or health supplement, including Chinese herbal medicines, within 14 days before the study.
6. Use of any medication that inhibits or induces hepatic drug metabolism within 30 days before the study, including but not limited to inducers such as barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazole, or inhibitors such as selective serotonin reuptake inhibitors, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines.
7. Participation in another clinical trial involving administration of an investigational drug within 3 months before the study.
8. Blood donation or significant blood loss of 200 mL or more, excluding menstrual blood loss, blood transfusion, or use of blood products within 3 months before enrollment.
9. Pregnant or breastfeeding women, or participants unable or unwilling to use one or more non-pharmacological contraceptive measures during the study.
10. Special dietary requirements, inability to comply with the standardized diet, or difficulty swallowing.
11. Consumption of more than 8 cups of tea, coffee, and/or caffeine-containing beverages per day, with 1 cup defined as 250 mL.
12. Positive nicotine test before the first dose, smoking more than 5 cigarettes per day within 3 months before the study, or inability to abstain from all tobacco products during the study.
13. Positive alcohol test before the first dose; regular alcohol consumption within 6 months before the study, defined as more than 14 units of alcohol per week, where 1 unit equals 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine; or inability to abstain from alcohol-containing products during the study.
14. Positive drug abuse screening before the first dose; use of soft drugs, such as marijuana, within 3 months before the study; or use of hard drugs, such as cocaine or phencyclidine, within 1 year before the study.
15. Abnormal vital signs, defined as systolic blood pressure below 90 mmHg or at least 140 mmHg, diastolic blood pressure below 60 mmHg or at least 90 mmHg, heart rate below 50 bpm or above 100 bpm; or clinically significant abnormalities in physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, or laboratory examinations, as determined by the investigator.
16. Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody.
17. Presence or history of cardiac disease, including but not limited to congenital long QT syndrome, torsades de pointes, or risk factors for torsades de pointes, such as cardiac insufficiency, hypokalemia, or a family history of long QT syndrome; current use of Class IA antiarrhythmic drugs, such as quinidine or procainamide, Class III antiarrhythmic drugs, such as amiodarone or sotalol, or other drugs known to affect the QT interval; or a screening Fridericia-corrected QT interval (QTcF) of at least 450 ms for males or at least 460 ms for females, PR interval greater than 200 ms, or QRS interval of at least 120 ms.
18. Receipt of any live vaccine within 30 days before the first dose.
19. Consumption of grapefruit-containing products or other beverages or foods that may affect drug absorption, distribution, metabolism, or excretion within 48 hours before the first dose.
20. Any other condition that, in the investigator's opinion, may prevent the participant from completing the study or make the participant unsuitable for enrollment.