Status:
UNKNOWN
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Prevention of Arterial and Venous Thrombosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmac...
Eligibility Criteria
Inclusion
- males or females, aged 18-55;
- body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg.
Exclusion
- previous medical history of coagulation or bleeding disorders;
- known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05369767
Start Date
May 24 2022
End Date
January 30 2023
Last Update
November 30 2022
Active Locations (1)
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1
Affiliated Drum Tower Hospital of Nanjing University Medical school
Nanjing, Jiangsu, China, 210008