Status:
COMPLETED
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
Lead Sponsor:
LG Life Sciences
Conditions:
Healthy Subjects
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
Eligibility Criteria
Inclusion
- 20-45 years old healthy males
- Body mass index 19.0 \~ 28.0 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02206867
Start Date
August 1 2014
End Date
February 1 2015
Last Update
June 15 2015
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