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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A: Aspirin + Clopidogrel + placebo or SHR2285 (dose 1) | Experimental |
| |
| group B :Aspirin + Clopidogrel + placebo or SHR2285 (dose 2) | Experimental |
| |
| group C: Aspirin + Ticagrelor + placebo or SHR2285 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin、clopidogrel、placebo or SHR2285 | Drug | groupA: Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and severity of adverse events. | from the first dose to 48hours after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 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. | from Day1 to Day8 after the first dose |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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| Aspirin、clopidogrel、placebo or SHR2285 | Drug | groupB: Aspirin + clopidogrel + placebo or SHR2285 (dose 2) |
|
| Aspirin、ticagrelor、placebo or SHR2285 | Drug | groupC: Aspirin + ticagrelor + placebo or SHR2285 |
|
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. |
| from Day1 to Day8 after the first dose |
| T1/2 | 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. | from Day1 to Day8 after the first dose |
| AUC0-last | 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. | from Day1 to Day8 after the first dose |
| Cmax,ss | 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. | from Day1 to Day8 after the first dose |
| Ctrough,ss | 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. | from Day1 to Day8 after the first dose |
| FXI activity | Clotting factor XI (FXI) activity | from Day1 to Day8 after the first dose |
| APTT | Change of activated partial thromboplastin time (APTT) from baseline | from Day1 to Day8 after the first dose |
| PT | Change of prothrombin time (PT) from baseline | from Day1 to Day8 after the first dose |
| INR | Change of international normalization ratio (INR) from baseline | from Day1 to Day8 after the first dose |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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