NCT01842516

Multiple Ascending Dose Study for LCB01-0371

A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics of LCB01-0371 in Healthy Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

* To investigate the PK characteristics of LCB01-0371 after a multiple oral dose * To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LCB01-0371 800mg	LCB0-0371 800mg
DRUG	LCB01-0371 1200mg	LCB01-0371 1200mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2013-04-29
• Last updated: 2014-11-17

Locations

1 site across 1 country: South Korea