Study of CM313 in Healthy Subjects

Phase 1 Unknown 51 enrolled Keymed Biosciences Co.Ltd

RandomizedSequentialQuadruple-blindTreatment

Summary

This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.

Timeline

Start: 2024-03-12
Primary completion: 2025-04-30
Completion: 2025-04-30

Publications

Yu S, Wu J, Zhao J, He J, Yan H, Zhang X, Yang Y, Song H, Hou Q, Guo B, Qiu Y, Chen B, Xue Y, Zhang J. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. Clin Transl Sci. 2025 Sep;18(9):e70334. doi: 10.1111/cts.70334.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LUMROTATUG	Monoclonal antibody	8 mg/kg	Subcutaneous
Subject	LUMROTATUG	Monoclonal antibody	150 mg	Subcutaneous
Subject	LUMROTATUG	Monoclonal antibody	300 mg	Subcutaneous
Subject	LUMROTATUG	Monoclonal antibody	600 mg	Subcutaneous

Indications

No indication recorded.