A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.

NCT ID: NCT03196804

Last Updated: 2018-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2017-11-15

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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LC28-0126

LC28-0126(IV)

Group Type EXPERIMENTAL

LC28-0126

Intervention Type DRUG

LC28-0126

Placebo

Placebo of LC28-0126

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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LC28-0126

LC28-0126

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Participation in a clinical research study within the previous 3 months
* Regular alcohol consumption \>21 units per week.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital, Clinical Trial Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32980184 (View on PubMed)

Other Identifiers

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LG-CYCL003

Identifier Type: -

Identifier Source: org_study_id

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