To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Thrombosis

Interventions

Aspirin、clopidogrel、placebo or SHR2285DRUG

groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；

Aspirin、clopidogrel、placebo or SHR2285DRUG

groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2)

Aspirin、ticagrelor、placebo or SHR2285DRUG

groupC： Aspirin + ticagrelor + placebo or SHR2285

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Number of subjects with adverse events and severity of adverse events.

Time frame: from the first dose to 48hours after the last dose

Secondary Outcomes

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.

Time frame: from Day1 to Day8 after the first dose

Tmax

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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