UnknownPhase 1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects

China64 participantsStarted 2022-05-24

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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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.

What they're measuring

To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: up to day 113

Trial details

NCT IDNCT05369767

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Prevention of Arterial and Venous Thrombosis trials