Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Phase 1
Active, not recruiting
- Conditions
- Prevention of Arterial and Venous Thrombosis
- Interventions
- Drug: SAD, SHR-2004Drug: SAD, SHR-2004 placebo
- Registration Number
- NCT05369767
- Lead Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- 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 pharmacodynamics of SHR-2004 injection in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAD, SHR-2004 SAD, SHR-2004 Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 injection SAD, SHR-2004 placebo SAD, SHR-2004 placebo Up to 6 cohorts of healthy subjects will receive a single dose of SHR-2004 placebo injection
- Primary Outcome Measures
Name Time Method To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs) up to day 113
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Affiliated Drum Tower Hospital of Nanjing University Medical school
🇨🇳Nanjing, Jiangsu, China