NCT02206867CompletedPhase 1
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
LG Life Sciences0 sites116 target enrollmentStarted: August 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 116
- Primary Endpoint
- Maximum measured concentration of the analyte in serum
Study Overview
Brief Summary
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Humira®
Active Comparator
Abbvie
Intervention: Humira (Biological)
LBAL
Experimental
Developed by LG Life Sciences
Intervention: LBAL (Biological)
Outcomes
Primary Outcomes
Maximum measured concentration of the analyte in serum
Time Frame: 0 to 65 days
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
Secondary Outcomes
No secondary outcomes reported
Investigators
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