A Trial of SHR6390 in Healthy Caucasian Volunteers

• 1. Healthy Caucasian male and female subjects aged 18 to 45 years, inclusive at screening
• 2. Male body weight ≥50 kg, female body weight ≥45 kg, BMI between 19.0 and 29.0 kg/m2, inclusive
• 3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
• 4. Female subjects agree not to be pregnant or lactating from beginning of the study screening and will maintain contraception for 90 days after trial completion
• 5. Males agree to use contraception with their female partner and refrain from donating sperm during the study and for at least 90 days after SHR6390 administration
• 6. Able and willing to abstain from caffeine- and xanthine-containing products, alcohol, grapefruit-related fruit juices, tobacco/nicotine-containing products, and alcohol for 48 hours prior to check-in until final PK blood sample
• 7. Able and willing to abstain from eating and drinking poppy seed-containing products and grapefruit-related fruits and juices
• 8. Able and willing to abstain from strenuous exercise
• 9. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria:

• 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or allergic disease
• 2. Had a severe infection, trauma or major surgery within 4 weeks of screening; plan to have a surgery during the trial
• 3. A past medical history of clinically significant cardiovascular conditions
• 4. Sitting systolic blood pressure (BP) ≥140 mmHg or \<90 mmHg; diastolic BP ≥90 mmHg or \<50 mmHg on a single measurement
• 5. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy
• 6. Subject has a history of type 1 hypersensitivity to any medication
• 7. Evidence of substance abuse or a history of substance abuse in the last two years
• 8. Subject is positive for drugs of abuse,cotinine or alcohol at screening and check-in; may be repeated once at the discretion of the investigator
• 9. History of severe hypoglycemia
• 10. Subjects who use more than 5 tobacco or nicotine-containing products per day or will not abstain from using these products starting from at least 48 hours prior to check-in and during the study
• 11. History of regular alcohol consumption in the past 3 months exceeding an average weekly intake of 14 standard drinks
• 12. Use of medications affecting liver metabolism within 1 month prior to dosing
• 13. Treatment with an investigational drug within 3 months or 5 half-lives
• 14. Blood donation or loss of more than 200 mL of blood within 1 month of dosing or 400 mL of blood within 3 months, or 400 mL within 3 months.
• 15. Any other major illness/condition that, in the investigator's judgment, substantially increased the risk associated with the subject's participation