NCT04945616已完成1 期
Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events and severity of adverse events.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc.
- •Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
排除标准
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold 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.
- •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.
研究组 & 干预措施
group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1)
Experimental
干预措施: Aspirin、clopidogrel、placebo or SHR2285 (Drug)
group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2)
Experimental
干预措施: Aspirin、clopidogrel、placebo or SHR2285 (Drug)
group C： Aspirin + Ticagrelor + placebo or SHR2285
Experimental
干预措施: Aspirin、ticagrelor、placebo or SHR2285 (Drug)
结局指标
主要结局
Number of subjects with adverse events and severity of adverse events.
时间窗: from the first dose to 48hours after the last dose
次要结局
- Cmax(from Day1 to Day8 after the first dose)
- Tmax(from Day1 to Day8 after the first dose)
- T1/2(from Day1 to Day8 after the first dose)
- AUC0-last(from Day1 to Day8 after the first dose)
- Cmax，ss(from Day1 to Day8 after the first dose)
- Ctrough，ss(from Day1 to Day8 after the first dose)
- FXI activity(from Day1 to Day8 after the first dose)
- PT(from Day1 to Day8 after the first dose)
- APTT(from Day1 to Day8 after the first dose)
- INR(from Day1 to Day8 after the first dose)
研究者
研究点 (1)
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