A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255

LG Chem100 enrolled

Overview

1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects 2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects 3. To evaluate bioavailability of LC51-0255

For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

100

Conditions

Healthy

Interventions

LC51-0255DRUG

0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

PlaceboDRUG

0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects aged 19\~45 years at screening. * Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive) Exclusion Criteria: * History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease * Exclusions Related to Laboratory Results: Platelet count \< 100,000/μL, Hgb \< 8.5 g/dL, Neutrophils \< 1.5 /μL, Absolute WBC count \< 3500/μL, Absolute lymphocyte count \< 800/μL

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

MTD determination

Safety and Tolerability

Time frame: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study

Secondary Outcomes

Pharmacokinetic: Peak Plasma Concentration (Cmax)

Cmax

Time frame: Cmax:168 hours post dose

Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)

AUC

Time frame: AUCinf:168 hours post dose

Data from ClinicalTrials.gov

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