Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

Study Overview
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Brief Summary
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The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects. To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Detailed Description
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Double blind, randomized, placebo control, multiple dose, dose escalation study

Official Title
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A Phase I Clinical Study, Multiple Dose 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 800mg BID
* Drug: LCB01-0371 1200mg BID
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male between 20 and 45 years of age at the time of screening Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements. Exclusion Criteria: History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s) History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy) History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics History of drug abuse or positive result at urine drug screening AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

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

Sexes Eligible for Study
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Male

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCB01-0371 800mg<br>LCB01-0371 800mg | Drug: LCB01-0371 800mg<br>* LCB01-0371 800mg<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: LCB01-0371 800mg BID<br>LCB01-0371 800mg BID | Drug: LCB01-0371 800mg BID<br>* LCB01-0371 800mg BID<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: LCB01-0371 1200mg BID<br>LCB01-0371 1200mg BID | Drug: LCB01-0371 1200mg BID<br>* LCB01-0371 1200mg BID<br>Drug: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo<br>LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No of Adverse events |  | From date of randomization until follow up after 3 days from last hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Cmax(Peak plasma concentration) | Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days | 0(predose), 0.5, 1, 2, 4, 8 and 12hours | 
| Pharmacokinetics: AUC(Area under the curve) | Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days | 0(predose), 0.5, 1, 2, 4, 8 and 12hours |