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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-06-15

Brief Summary

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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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Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1)

Group Type EXPERIMENTAL

Aspirin、clopidogrel、placebo or SHR2285

Intervention Type DRUG

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

group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2)

Group Type EXPERIMENTAL

Aspirin、clopidogrel、placebo or SHR2285

Intervention Type DRUG

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

group C： Aspirin + Ticagrelor + placebo or SHR2285

Group Type EXPERIMENTAL

Aspirin、ticagrelor、placebo or SHR2285

Intervention Type DRUG

groupC： Aspirin + ticagrelor + placebo or SHR2285

Interventions

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Aspirin、clopidogrel、placebo or SHR2285

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

Intervention Type DRUG

Aspirin、clopidogrel、placebo or SHR2285

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

Intervention Type DRUG

Aspirin、ticagrelor、placebo or SHR2285

groupC： Aspirin + ticagrelor + placebo or SHR2285

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes