Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBAL

Biological

Anti-inflammatory agents

Other names: Adalimumab

Humira

Biological

Anti-inflammatory agents

Other names: Adalimumab

Primary outcomes

Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity

Time frame: 0 to 65 days
Maximum measured concentration of the analyte in serum

Time frame: 0 to 65 days

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 1, 2014
Registry last updated: Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed