IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

Phase 1 Completed 24 enrolled LigaChem Biosciences, Inc.

RandomizedParallel-groupSingle-blindTreatment

Summary

Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose

Timeline

Start: 2016-09
Primary completion: 2017-07
Completion: 2017-07

Publications

Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delpazolid	Small molecule	200 mg	Intravenous
Subject	Delpazolid	Small molecule	400 mg	Intravenous
Subject	Delpazolid	Small molecule	800 mg	Intravenous

Indications

No indication recorded.