Status:
COMPLETED
The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Thrombosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect stud...
Eligibility Criteria
Inclusion
- Healthy subjects, aged 18-55 (including boundary);
- Body mass index (BMI) between 18 to 28 kg/m2 (including boundary), male body weight ≥50 kg and \<90 kg , female body weight ≥45kg and \<90kg;
- Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
- Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Exclusion
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> upper limit of normal (ULN) during screening/baseline.
- Serum creatinine\> ULN during screening/baseline.
- Positive faecal occult blood
- Abnormal coagulation function.
- A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
- Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
- Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
- Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
- 3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
- Female subjects who did not receive contraception at least 30 days before administration and etc.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04472819
Start Date
August 28 2020
End Date
May 31 2021
Last Update
September 28 2021
Active Locations (2)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410006