IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

Study Overview
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Brief Summary
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Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose

Official Title
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A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: LCB01-0371
* Drug: LCB01-0371 400mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male between 19 and 39 years of age at the time of screening Subjects with body mass index (BMI) between 19 and 27 at the time of screening Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 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 gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCB01-0371 200mg<br>LCB01-0371 IV 200 mg | Drug: LCB01-0371<br>* Cohort1 & 3: Placebo-controlled, Single ascending dose administration<br>* Other names: LCB01-0371 or placebo;|
| Experimental: LCB01-0371 400mg<br>LCB01-0371 IV 400 mg | Drug: LCB01-0371<br>* Cohort1 & 3: Placebo-controlled, Single ascending dose administration<br>* Other names: LCB01-0371 or placebo;Drug: LCB01-0371 400mg<br>* Cohort 2: Crossover designed administration<br>* Other names: LCB01-0371 400mg 2 tablet;|
| Experimental: LCB01-0371 800mg<br>LCB01-0371 IV 800 mg | Drug: LCB01-0371<br>* Cohort1 & 3: Placebo-controlled, Single ascending dose administration<br>* Other names: LCB01-0371 or placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Peak Plasma Concentration(Cmax) of LCB01-0371 |  | through study completion per patient, an average of 8 days (+ - 1 D) |