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

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LCB01-0371
* Drug: Linezolid


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 and 27 at the time of screening Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days of 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, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s). History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) 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 of drug abuse or positive result at urine drug screening test AST, ALT, r-GT, billirubin(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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCB01-0371<br>active | Drug: LCB01-0371<br>* LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)<br>|
| Experimental: Linezolid<br>comparator | Drug: Linezolid<br>* Linezolid 600 mg (Cohort 9) none<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LCB01-0371