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

Phase 1 Unknown 64 enrolled Beijing Suncadia Pharmaceuticals Co., Ltd

RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start: 2022-05-24
Primary completion: 2023-01-30
Completion: 2023-01-30

Publications

Ma T, Weng Z, Cao B, Dong Y, Deng C, Huang L, Yang Y, Wang Y, Shen C, Wang L, Shen K, Li J. The first-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the factor XI monoclonal antibody SHR-2004 in healthy subjects. Expert Opin Investig Drugs. 2024 Oct;33(10):1075-1082. doi: 10.1080/13543784.2024.2391837. Epub 2024 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHR-2004	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	SHR-2004	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	SHR-2004	Monoclonal antibody	0.5 mg/kg	Intravenous
Subject	SHR-2004	Monoclonal antibody	1 mg/kg	Intravenous
Subject	SHR-2004	Monoclonal antibody	3 mg/kg	Intravenous
Subject	SHR-2004	Monoclonal antibody	4.5 mg/kg	Intravenous

Indications

No indication recorded.