NCT01725620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2012

Longer than P75 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

November 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

November 9, 2012

Last Update Submit

January 29, 2015

Conditions

Healthy

Study Arms (2)

Group 1

EXPERIMENTAL

Enbrel, LBEC0101

Drug: LBEC0101 (Etanercept 25mg)Drug: Enbrel (Etanercept 25mg)

Group 2

EXPERIMENTAL

LBEC0101, Enbrel

Drug: LBEC0101 (Etanercept 25mg)Drug: Enbrel (Etanercept 25mg)

Interventions

LBEC0101 (Etanercept 25mg)DRUG
Group 1Group 2
Enbrel (Etanercept 25mg)DRUG
Group 1Group 2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • The tuberculosis patient of latent tuberculosis patient
  • Hypersensitivity response to the test and comparator drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital, Clinical Trial Center

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28551775DERIVED

MeSH Terms

Interventions

LBEC0101Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D.

    Seoul National University College of Medicine and Hospitaal

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

KR(1)