Multiple Ascending Dose Study for LCB01-0371

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: LCB01-0371 800mg
* Drug: LCB01-0371 1200mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test Able to donate blood during study period and follow visit. Agree to continue to use a reliable method of birth control until 60 days after study completion. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Exclusion Criteria: History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s). History of gastrointestinal problem which is affect to absorption within 6 months from screening 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. History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCB01-0371 800mg<br>LCB01-0371 800mg | Drug: LCB01-0371 800mg<br>* LCB0-0371 800mg<br>* Other names: LCB0-0371 800mg;|
| Experimental: LCB01-0371 1200mg<br>LCB01-0371 1200mg | Drug: LCB01-0371 1200mg<br>* LCB01-0371 1200mg<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |