The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Thrombus

Treatments: Drug: Placebo; Drug: SHR2285 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04229433

SHR2285-102

Details and patient eligibility

About

The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion criteria

1. males or females, aged 18-45.
2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
3. body mass index (BMI) between 18 to 28.
4. Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
2. Serum creatinine> 1X ULN during screening/baseline.
3. Abnormal coagulation function.
4. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
5. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
6. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
7. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.

8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.

9.Female subjects who did not receive contraception at least 30 days before administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

SHR2285

Experimental group

Description:

Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.

Treatment:

Drug: Placebo

Drug: SHR2285 tablet

Placebo

Experimental group

Description:

Participants received one of 3 dose levels of placebo administered as multiple oral doses.

Treatment:

Drug: Placebo

Drug: SHR2285 tablet