Multiple Ascending Dose Study for LCB01-0371

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LCB01-0371 1200mg; Drug: Placebo; Drug: LCB01-0371 800mg

• Registration Number: NCT01842516
• Lead Sponsor: LigaChem Biosciences, Inc.

Brief 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

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-20
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
3. Able to donate blood during study period and follow visit.
4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria

1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
2. History of gastrointestinal problem 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 drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LCB01-0371 1200mg	LCB01-0371 1200mg	LCB01-0371 1200mg
Placebo	Placebo	Placebo
LCB01-0371 800mg	LCB01-0371 800mg	LCB01-0371 800mg

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 7 days

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of LCB01-0371	Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371	Up to 7 days

Trial Locations

Locations (1)

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