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

A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03174613

Enrollment

100

Registered

2017-06-02

Start date

2017-05-31

Completion date

2019-07-11

Last updated

2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed 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.

Interventions

DRUGLC51-0255

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blind

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
MTD determination	Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study	Safety and Tolerability

Secondary

Measure	Time frame	Description
Pharmacokinetic: Peak Plasma Concentration (Cmax)	Cmax:168 hours post dose	Cmax
Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)	AUCinf:168 hours post dose	AUC

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026