Pharmacokinetics and Safety Study of LBAL in Healthy Subj... | NCT02206867

Studies
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

NCT02206867

Sponsor

LG Life Sciences

Status

Completed

Last Update Posted

Jun 15, 2015Estimated

Enrollment

116Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

LBAL
Humira

Countries

Not provided

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

Jun 2015

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

Aug 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jul 30, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Aug 1, 2014Estimated

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

Jun 12, 2015

Last Update Posted Date

Jun 15, 2015Estimated

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

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LBAL	Experimental	Developed by LG Life Sciences	Biological: LBAL
Humira®	Active Comparator	Abbvie	Biological: Humira

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LBAL	Biological	Anti-inflammatory agents	LBAL	Adalimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity		0 to 65 days
Maximum measured concentration of the analyte in serum		0 to 65 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-45 years old healthy males
Body mass index 19.0 ~ 28.0 kg/m2

Exclusion Criteria:

Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
Fever greater than 38.3℃ within a week prior to administration of study drug
Previous or current drug abuse

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., M.B.A	Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided