The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Inclusion criteria

• Healthy subjects, aged 18-55 (including boundary);
• Body mass index (BMI) between 18 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg;
• Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
• Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.

Exclusion criteria

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > upper limit of normal (ULN) during screening/baseline.
• Serum creatinine> ULN during screening/baseline.
• Positive faecal occult blood
• Abnormal coagulation function.
• A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
• Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
• Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
• Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.

9.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

10.Female subjects who did not receive contraception at least 30 days before administration and etc.