Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®
A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers
1 other identifier
interventional
36
1 country
1
Brief Summary
To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jun 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 18, 2011
February 1, 2011
5 months
June 15, 2010
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Etanercept levels in blood
22 day
Study Arms (2)
Group 1
EXPERIMENTALGroup 2
EXPERIMENTALInterventions
Eligibility Criteria
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 or latent tuberculosis patient
- Hypersensitivity response to the test and comparator drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Sang Yu, M.D., Ph.D.
Seoul National University College of Medicine and Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 15, 2010
First Posted
June 17, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
January 1, 2011
Last Updated
February 18, 2011
Record last verified: 2011-02