Healthy Subjects
Conditions
Brief summary
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 20-45 years old healthy males 2. Body mass index 19.0 \ 28.0 kg/m2
Exclusion criteria
1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB 2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration 3. Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders 4. 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) 5. Fever greater than 38.3℃ within a week prior to administration of study drug 6. Previous or current drug abuse
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed