Multiple Ascending Dose Study for LCB01-0371

Phase 1 Completed 30 enrolled LigaChem Biosciences, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary * To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose * To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects * To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects

Timeline

Start: 2013-03
Primary completion: 2013-07
Completion: 2013-12

Publications

Cho YS, Lim HS, Cho YL, Nam HS, Bae KS. Multiple-dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral LCB01-0371 in Healthy Male Volunteers. Clin Ther. 2018 Dec;40(12):2050-2064. doi: 10.1016/j.clinthera.2018.10.007. Epub 2018 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delpazolid	Small molecule	800 mg	Oral
Subject	Delpazolid	Small molecule	1200 mg	Oral

Indications

No indication recorded.