Safety and Tolerability of SHR-1918 in Healthy Subjects

Phase 1 Unknown 72 enrolled Beijing Suncadia Pharmaceuticals Co., Ltd

RandomizedParallel-groupQuadruple-blindOther

Summary

The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.

Timeline

Start: 2022-06-27
Primary completion: 2023-12-11
Completion: 2023-12-12

Publications

Qin R, Ye L, Duan L, Li M, He W, Mei X, Li D, Jin R, Lv C, Zhu M, Wang S, Xie Z. SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Pharmacokinet. 2025 Aug;64(8):1245-1253. doi: 10.1007/s40262-025-01539-8. Epub 2025 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHR-1918	Monoclonal antibody	100 mg	Subcutaneous
Subject	SHR-1918	Monoclonal antibody	300 mg	Subcutaneous
Subject	SHR-1918	Monoclonal antibody	450 mg	Subcutaneous
Subject	SHR-1918	Monoclonal antibody	750 mg	Subcutaneous
Subject	SHR-1918	Monoclonal antibody	900 mg	Subcutaneous
Subject	SHR-1918	Monoclonal antibody	1200 mg	Subcutaneous

Safety and Tolerability of SHR-1918 in Healthy Subjects

Summary

Timeline

Publications

Drugs

Indications