The PK/PD Study of SHR2285 Tablets in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Placebo; Drug: SHR2285

Study type: Interventional

Funder types: Industry

Identifiers

NCT03769831

SHR2285-101

Details and patient eligibility

About

Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant therapies is bleeding. The primary objective of this study is to assess the safety and tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.

Enrollment: 28 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 and 50mmHg ≤DBP<90mmHg;
3. body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Exclusion criteria

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1X ULN during screening/baseline;
2. Abnormal coagulation function;
3. A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
4. Subjects with severe trauma or surgery within 3 months prior to the screening；
5. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
8. Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

SHR2285

Experimental group

Description:

Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.

Treatment:

Drug: SHR2285

Placebo

Experimental group

Description:

Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.

Treatment:

Drug: Placebo