NCT03174613

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: LG Chem · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LC51-0255	0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
DRUG	Placebo	0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

Timeline

• Start date: 2017-05-31
• Primary completion: 2019-06-12
• Completion: 2019-07-11
• First posted: 2017-06-02
• Last updated: 2020-09-18

Locations

1 site across 1 country: South Korea