Study to Compare the Safety and Pharmacokinetic Character... | NCT01145950

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

NCT01145950

Sponsor

LG Life Sciences

Status

Completed

Last Update Posted

Feb 18, 2011Estimated

Enrollment

36Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

LBEC0101
Enbrel

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jun 15, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2011

Last Update Posted Date

Feb 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental		Drug: LBEC0101
Group 2	Experimental		Drug: Enbrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LBEC0101	Drug	Etanercept 25mg, single dose	Group 1
Enbrel

Measure	Description	Time Frame
Etanercept levels in blood		22 day

Eligibility Module

Eligibility Criteria

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 or latent tuberculosis patient
Hypersensitivity response to the test and comparator drugs

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-Sang Yu, M.D., Ph.D.	Seoul National University College of Medicine and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C000626868	LBEC0101
D000068800	Etanercept

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided