A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study

Phase 1 Completed 70 enrolled LigaChem Biosciences, Inc.

RandomizedSingle-groupQuadruple-blindTreatment

Summary

Primary \- To investigate the safety and tolerability of LCB01-0371 after a single oral dose Secondary * To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose * To investigate the safety of LCB01-0371 after a single oral dose

Timeline

Start: 2012-03
Primary completion: 2012-12
Completion: 2013-02

Publications

Cho YS, Lim HS, Lee SH, Cho YL, Nam HS, Bae KS. Pharmacokinetics, Pharmacodynamics, and Tolerability of Single-Dose Oral LCB01-0371, a Novel Oxazolidinone with Broad-Spectrum Activity, in Healthy Volunteers. Antimicrob Agents Chemother. 2018 Jun 26;62(7):e00451-18. doi: 10.1128/AAC.00451-18. Print 2018 Jul.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delpazolid	Small molecule	50 mg	Oral
Subject	Delpazolid	Small molecule	100 mg	Oral
Subject	Delpazolid	Small molecule	200 mg	Oral
Subject	Delpazolid	Small molecule	400 mg	Oral
Subject	Delpazolid	Small molecule	600 mg	Oral
Subject	Linezolid	Other / unclassified	600 mg	Oral

Indications

No indication recorded.