Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
NCT ID: NCT02206867
Last Updated: 2015-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
116 participants
INTERVENTIONAL
2014-08-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LBAL
Developed by LG Life Sciences
LBAL
Anti-inflammatory agents
Humira®
Abbvie
Humira
Anti-inflammatory agents
Interventions
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LBAL
Anti-inflammatory agents
Humira
Anti-inflammatory agents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body mass index 19.0 \~ 28.0 kg/m2
Exclusion Criteria
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
20 Years
45 Years
MALE
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Kyung-Sang Yu, M.D., Ph.D., M.B.A
Role: PRINCIPAL_INVESTIGATOR
Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital
Other Identifiers
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LG-ALCL001
Identifier Type: -
Identifier Source: org_study_id
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