The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I
 trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered
 single dose and multiple doses.
Inclusion Criteria:

 1. males or females, aged 18-45.

 2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg;
 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.

 3. body mass index (BMI) between 18 to 28.

 4. Participant in general good health. No clinically significant findings in vital signs,
 physical examination, 12-lead ECG ,X-ray and laboratory parameters.

 Exclusion Criteria:

 1. males or females, aged 18-45.

 2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg;
 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.

 3. body mass index (BMI) between 18 to 28.

 4. Participant in general good health. No clinically significant findings in vital signs,
 physical examination, 12-lead ECG ,X-ray and laboratory parameters.

 Exclusion Criteria:

 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total
 bilirubin/direct bilirubin > 1X ULN during screening/baseline.

 2. Serum creatinine> 1X ULN during screening/baseline.

 3. Abnormal coagulation function.

 4. A clinical history of coagulation dysfunction; subjects with adverse reaction of
 antiplatelet drugs or anticoagulant drugs.

 5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3
 months prior to the screening.

 6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before
 administration.

 7. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination,
 hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were
 positive.

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

 9.Female subjects who did not receive contraception at least 30 days before administration.