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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Aspirin、ticagrelor、placebo or SHR2285; Drug: Aspirin、clopidogrel、placebo or SHR2285

Study type: Interventional

Funder types: Industry

Identifiers

NCT04945616

SHR2285-106

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

52 participants in 3 patient groups

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

Experimental group

Treatment:

Drug: Aspirin、clopidogrel、placebo or SHR2285

Drug: Aspirin、clopidogrel、placebo or SHR2285

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

Experimental group

Treatment:

Drug: Aspirin、clopidogrel、placebo or SHR2285

Drug: Aspirin、clopidogrel、placebo or SHR2285

group C： Aspirin + Ticagrelor + placebo or SHR2285

Experimental group

Treatment:

Drug: Aspirin、ticagrelor、placebo or SHR2285