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Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®

NCT ID: NCT01725620

Last Updated: 2015-01-30

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

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To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Enbrel, LBEC0101

Group Type EXPERIMENTAL

LBEC0101 (Etanercept 25mg)

Intervention Type DRUG

Enbrel (Etanercept 25mg)

Intervention Type DRUG

Group 2

LBEC0101, Enbrel

Group Type EXPERIMENTAL

LBEC0101 (Etanercept 25mg)

Intervention Type DRUG

Enbrel (Etanercept 25mg)

Intervention Type DRUG

Interventions

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LBEC0101 (Etanercept 25mg)

Intervention Type DRUG

Enbrel (Etanercept 25mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males, 20 to 45 years of age the moment of screening
* Body mass index is between 18.0 and 30.0 kg/m

Exclusion Criteria

* The tuberculosis patient of latent tuberculosis patient
* Hypersensitivity response to the test and comparator drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospitaal

Locations

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Seoul National University Hospital, Clinical Trial Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects. BioDrugs. 2017 Aug;31(4):349-355. doi: 10.1007/s40259-017-0230-9.

Reference Type DERIVED
PMID: 28551775 (View on PubMed)

Other Identifiers

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LG-ECCL003

Identifier Type: -

Identifier Source: org_study_id