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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371; Drug: Linezolid

• Registration Number: NCT01554995
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief 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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Status Verified: 2013-04
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

1. Healthy Male between 20 and 45 years of age at the time of screening
2. Subjects with body mass index (BMI) between 20 and 27 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption within 6 months from screening
3. History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
4. History of drug abuse or positive result at urine drug screening test
5. AST, ALT, r-GT, billirubin(total) values over than 1.5 times of ULN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCB01-0371	LCB01-0371	active
Linezolid	Linezolid	comparator

Primary Outcome Measures

Name	Time	Method
safety and tolerability	7 days	Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul,, Korea, Republic of