Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02206867
Status:
COMPLETED
Last Update Posted:
2015-06-15
First Post:
2014-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2014-07-30', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity', 'timeFrame': '0 to 65 days'}, {'measure': 'Maximum measured concentration of the analyte in serum', 'timeFrame': '0 to 65 days'}]}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20-45 years old healthy males\n2. Body mass index 19.0 \\~ 28.0 kg/m2\n\nExclusion Criteria:\n\n1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB\n2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration\n3. Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders\n4. 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)\n5. Fever greater than 38.3℃ within a week prior to administration of study drug\n6. Previous or current drug abuse'}, 'identificationModule': {'nctId': 'NCT02206867', 'briefTitle': 'Pharmacokinetics and Safety Study of LBAL in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'LG-ALCL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LBAL', 'description': 'Developed by LG Life Sciences', 'interventionNames': ['Biological: LBAL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Humira®', 'description': 'Abbvie', 'interventionNames': ['Biological: Humira']}], 'interventions': [{'name': 'LBAL', 'type': 'BIOLOGICAL', 'otherNames': ['Adalimumab'], 'description': 'Anti-inflammatory agents', 'armGroupLabels': ['LBAL']}, {'name': 'Humira', 'type': 'BIOLOGICAL', 'otherNames': ['Adalimumab'], 'description': 'Anti-inflammatory agents', 'armGroupLabels': ['Humira®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyung-Sang Yu, M.D., Ph.D., M.B.A', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}