NCT03196804

Brief Summary

To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2017

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

Study Start

First participant enrolled

June 7, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

June 20, 2017

Last Update Submit

April 10, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    18 days

Secondary Outcomes (2)

  • Cmax

    up to 6 days post-dose

  • AUC

    up to 6 days post-dose

Study Arms (2)

LC28-0126

EXPERIMENTAL

LC28-0126(IV)

Drug: LC28-0126

Placebo

PLACEBO COMPARATOR

Placebo of LC28-0126

Drug: Placebo

Interventions

LC28-0126DRUG

LC28-0126

LC28-0126
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects between the ages of 19 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 3 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

Related Publications (1)

  • Kim E, Hwang I, Lee S, Oh J, Chung H, Jin M, Kim SH, Yu KS. Pharmacokinetics and Tolerability of LC28-0126, a Novel Necrosis Inhibitor, After Multiple Ascending Doses: A Phase I Randomized, Double-blind, Placebo-controlled Study in Healthy Male Subjects. Clin Ther. 2020 Oct;42(10):1946-1954.e2. doi: 10.1016/j.clinthera.2020.08.011. Epub 2020 Sep 24.

    PMID: 32980184DERIVED

Study Design

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

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 23, 2017

Study Start

June 7, 2017

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)