Single-Dose Study of MT203

Phase 1 Completed 32 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.

Timeline

Start: 2014-11
Primary completion: 2015-05
Completion: 2015-05

Publications

Tanaka S, Harada S, Hiramatsu N, Nakaya R, Kawamura M. Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men . Int J Clin Pharmacol Ther. 2018 Nov;56(11):507-517. doi: 10.5414/CP203235.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Namilumab	Monoclonal antibody	80 mg	Subcutaneous
Subject	Namilumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Namilumab	Monoclonal antibody	300 mg	Subcutaneous

Indications

No indication recorded.