Study to Investigate the Safety and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

A Dose Blocked-randomized, Double-blind, Placebo-controlled, Single Dosing and Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01737424

Enrollment

Registered

2012-11-29

Start date

2012-12-31

Completion date

2013-09-30

Last updated

2014-03-14

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

Conditions

Healthy

Brief summary

To investigate the safety, tolerability and pharmacokinetic characteristics of LC28-0126 in healthy male subjects

Interventions

DRUGLC28-0126

LC28-0126

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects between the ages of 20 and 45 years at screening. * Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)

Exclusion criteria

* Participation in a clinical research study within the previous 2 months * Regular alcohol consumption \>21 units per week.

Design outcomes

Primary

Measure	Time frame
Adverse events	12 days

Secondary

Measure	Time frame
Cmax	up to 6 days post-dose
AUC	up to 6 days post-dose

Countries

South Korea

Outcome results

None listed

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