NCT01737424

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

November 27, 2012

Last Update Submit

March 13, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    12 days

Secondary Outcomes (2)

  • Cmax

    up to 6 days post-dose

  • AUC

    up to 6 days post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

LC28-0126

EXPERIMENTAL

LC28-0126(IV)

Drug: LC28-0126

Interventions

LC28-0126DRUG

LC28-0126

LC28-0126
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, 110-744, South Korea

Location

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

November 29, 2012

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

KR(1)