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

LG Chem

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: LC51-0255

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03174613

LG-SGCL001

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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