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

NCT01554995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-11-17

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • LigaChem Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kyun-Seop Bae, M.D., Ph. D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554995 on ClinicalTrials.gov