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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174613
• Other study ID #: LG-SGCL001
• Status: Completed
• Phase: Phase 1
• Start date: May 31, 2017
• Est. completion date: July 11, 2019

Study information

• Verified date: September 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 11, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LC51-0255
0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
• Placebo
0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD determination	Safety and Tolerability	Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study
Secondary	Pharmacokinetic: Peak Plasma Concentration (Cmax)	Cmax	Cmax:168 hours post dose
Secondary	Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)	AUC	AUCinf:168 hours post dose