Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01725620
Status:
COMPLETED
Last Update Posted:
2015-01-30
First Post:
2012-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626868', 'term': 'LBEC0101'}, {'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-09', 'lastUpdatePostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28551775', 'type': 'DERIVED', 'citation': 'Lee H, Chung H, Lee S, Lee H, Yang SM, Yoon SH, Cho JY, Jang IJ, Yu KS. LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects. BioDrugs. 2017 Aug;31(4):349-355. doi: 10.1007/s40259-017-0230-9.'}]}, 'descriptionModule': {'briefSummary': 'To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator, Enbrel® 25mg.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males, 20 to 45 years of age the moment of screening\n* Body mass index is between 18.0 and 30.0 kg/m\n\nExclusion Criteria:\n\n* The tuberculosis patient of latent tuberculosis patient\n* Hypersensitivity response to the test and comparator drugs'}, 'identificationModule': {'nctId': 'NCT01725620', 'briefTitle': 'Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compate the Safety and Pharmacokinetic Characteristics of LBEC0101(Etanercept) 25mg With Those of Enbrel® 25mg After Subcutaneous Injection in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'LG-ECCL003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Enbrel, LBEC0101', 'interventionNames': ['Drug: LBEC0101 (Etanercept 25mg)', 'Drug: Enbrel (Etanercept 25mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'LBEC0101, Enbrel', 'interventionNames': ['Drug: LBEC0101 (Etanercept 25mg)', 'Drug: Enbrel (Etanercept 25mg)']}], 'interventions': [{'name': 'LBEC0101 (Etanercept 25mg)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Enbrel (Etanercept 25mg)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital, Clinical Trial Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Sang Yu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine and Hospitaal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}