To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1)
|
Drug: Aspirin、clopidogrel、placebo or SHR2285
groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；
|
| Experimental: group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2)
|
Drug: Aspirin、clopidogrel、placebo or SHR2285
groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
|
| Experimental: group C： Aspirin + Ticagrelor + placebo or SHR2285
|
Drug: Aspirin、ticagrelor、placebo or SHR2285
groupC： Aspirin + ticagrelor + placebo or SHR2285
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with adverse events and severity of adverse events. [from the first dose to 48hours after the last dose]
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy subjects, aged 18-55 (including boundary);
-
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;
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Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc.
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Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Exclusion Criteria:
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Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold ULN during screening/baseline.
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Serum creatinine> ULN during screening/baseline.
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Positive faecal occult blood
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Abnormal coagulation function.
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A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
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Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
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Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
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Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
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3 months prior to screening involved in any drug or medical device clinical studies. .
-
Female subjects who did not receive contraception at least 30 days before administration and etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | 210008 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR2285-106