Status:
COMPLETED
The PK/PD Study of SHR2285 Tablets in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Thrombosis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 bleed...
Eligibility Criteria
Inclusion
- males or females, aged 18-45
- subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP\<140mmHg and 50mmHg ≤DBP\<90mmHg;
- 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
- Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray
Exclusion
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin \> 1X ULN during screening/baseline;
- Abnormal coagulation function;
- A clinical history of coagulation dysfunction；subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
- Subjects with severe trauma or surgery within 3 months prior to the screening；
- Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months pre-dose;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;
- Pregnant or Serum β-hCG \> 5mIU/mL at baseline or women who are breastfeeding; etc.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03769831
Start Date
February 25 2019
End Date
July 22 2019
Last Update
May 24 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032