Overview
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-01-30
2023-01-30
Target enrollment:
0
0
Participant gender:
All
All
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 pharmacodynamics of SHR-2004 injection in healthy subjects.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Criteria
Inclusion Criteria:1. males or females, aged 18-55;
2. 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 Criteria:
1. previous medical history of coagulation or bleeding disorders;
2. known risks of bleeding or thrombosis, such as recurrent gingival bleeding,
spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk
bleeding diseases.