NCT02206867

Brief Summary

To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

July 30, 2014

Last Update Submit

June 12, 2015

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

LBAL

EXPERIMENTAL

Developed by LG Life Sciences

Biological: LBAL

Humira®

ACTIVE COMPARATOR

Abbvie

Biological: Humira

Interventions

LBALBIOLOGICAL

Anti-inflammatory agents

Also known as: Adalimumab
LBAL
HumiraBIOLOGICAL

Anti-inflammatory agents

Also known as: Adalimumab
Humira®

Eligibility Criteria

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

You may qualify if:

  • years old healthy males
  • Body mass index 19.0 \~ 28.0 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Kyung-Sang Yu, M.D., Ph.D., M.B.A

    Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06