Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

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

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

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