NCT01554995

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

* 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LCB01-0371	LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)
DRUG	Linezolid	Linezolid 600 mg (Cohort 9) none

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2012-03-15
• Last updated: 2014-11-17

Locations

1 site across 1 country: South Korea