Thrombosis
Conditions
Brief summary
The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.
Interventions
DRUGAspirin、clopidogrel、placebo or SHR2285
groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；
DRUGAspirin、ticagrelor、placebo or SHR2285
groupC： Aspirin + ticagrelor + placebo or SHR2285
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects, aged 18-55 (including boundary); 2. Body mass index (BMI) between 19 to 28 kg/m2 (including boundary), male body weight ≥50 kg and \<90 kg , female body weight ≥45kg and \<90kg; 3. Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc. 4. Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Exclusion criteria
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> 1.2 fold ULN during screening/baseline. 2. Serum creatinine\> ULN during screening/baseline. 3. Positive faecal occult blood 4. Abnormal coagulation function. 5. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs. 6. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening. 7. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration. 8. 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. . 10. Female subjects who did not receive contraception at least 30 days before administration and etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events and severity of adverse events. | from the first dose to 48hours after the last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | from Day1 to Day8 after the first dose | Time to maximum observed serum concentration (Tmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations. |
| T1/2 | from Day1 to Day8 after the first dose | Time to elimination half-life (T1/2) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations. |
| AUC0-last | from Day1 to Day8 after the first dose | Area under the plasma concentration versus time curve (AUC0-last) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations. |
| Cmax，ss | from Day1 to Day8 after the first dose | Steady-state peak concentration (Cmax，ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations. |
| Cmax | from Day1 to Day8 after the first dose | Maximum observed serum concentration (Cmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite steady state after multiple administrations. |
| FXI activity | from Day1 to Day8 after the first dose | Clotting factor XI (FXI) activity |
| APTT | from Day1 to Day8 after the first dose | Change of activated partial thromboplastin time (APTT) from baseline |
| PT | from Day1 to Day8 after the first dose | Change of prothrombin time (PT) from baseline |
| INR | from Day1 to Day8 after the first dose | Change of international normalization ratio (INR) from baseline |
| Ctrough，ss | from Day1 to Day8 after the first dose | Steady state valley concentration (Ctrough，ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations. |
Countries
China
Outcome results
None listed