Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: Humira; Biological: LBAL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02206867

LG-ALCL001

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

LBAL

Experimental group

Description:

Developed by LG Life Sciences

Treatment:

Biological: LBAL

Humira®

Active Comparator group

Description:

Abbvie

Treatment:

Biological: Humira