A Study of HS-10353 in Chinese Participants.

Exclusion Criteria

• •1. Pregnant and breastfeeding female.
• •2. Volunteers with a history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematological, metabolic and other systemic diseases, who are not suitable to participate in this study as assessed by the investigator.
• •3. The results of vital signs, physical examination, laboratory examination and 12-lead ECG during screening were abnormal with clinical significance.
• •4. Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb) or syphilis antibody is positive
• •5. Volunteers had a history of drug dependence or abuse.
• •6. A heavy smoker or smokers who smoked 5 or more cigarettes per day for 3 months prior to screening or tested positive for nicotine during screening.
• •7. A history of alcohol abuse or a single consumption of more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 150 mL of wine) in the nearly two weeks prior to screening or a positive breath test for alcohol at screening.
• •8. Participate in clinical trials of any drug or medical device within 3 months prior to screening.
• •9. Any medication taken within 2 weeks of administration, including prescription, over-the-counter, and herbal medicines.
• •10. Diet or dietary treatment or significant change in dietary habits within 30 days prior to administration for whatever reason.
• •11. Volunteers who have difficulty swallowing solid tablets or capsule.
• •12. Volunteers with difficulty in blood collection, unable to tolerate multiple venous blood collection and any blood collection contraindications.
• •1. Subject has a history of suicide attempt.
• •2. Subject has a recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, or eyes, ears, nose, and throat disorders, or any other acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
• •3. Subject has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time (ie, at least 4 weeks of treatment).
• •4. Subject has detectable hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody at screening.
• •5. Subject has active psychosis per Investigator assessment.
• •6. Subject has a medical history of seizures.
• •7. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
• •8. Subject has had exposure to another investigational medication or device within 30 days prior to screening.
• •9. Subject has had administration of psychotropics that have been initiated within 14 days prior to screening and/or are not being taken at a stable dose.
• •10. Use of any known strong inhibitors and/or inducers of cytochrome P450 (CYP)3A4 within the 14 days or five half-lives (whichever is longer) or consumed grapefruit juice, grapefruit, Seville oranges, or products containing these within 30 days prior to receiving the first dose of study drug.