Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-28 @ 10:01 PM
Study NCT ID:
NCT02326233
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbregistry@samsung.com', 'title': 'Director of Clinical Trials', 'organization': 'Samsung Bioepis Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5', 'otherNumAtRisk': 95, 'otherNumAffected': 39, 'seriousNumAtRisk': 95, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5', 'otherNumAtRisk': 94, 'otherNumAffected': 28, 'seriousNumAtRisk': 94, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'OG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}], 'classes': [{'categories': [{'measurements': [{'value': '2743.2', 'spread': '1081.76', 'groupId': 'OG000'}, {'value': '2503.3', 'spread': '1043.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose', 'unitOfMeasure': 'h·μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'OG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}], 'classes': [{'categories': [{'measurements': [{'value': '2329.2', 'spread': '733.30', 'groupId': 'OG000'}, {'value': '2182.2', 'spread': '724.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose', 'unitOfMeasure': 'h·μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'OG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}], 'classes': [{'categories': [{'measurements': [{'value': '3.803', 'spread': '1.0697', 'groupId': 'OG000'}, {'value': '3.673', 'spread': '0.8810', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'OG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}], 'classes': [{'categories': [{'measurements': [{'value': '168.000', 'groupId': 'OG000', 'lowerLimit': '24.00', 'upperLimit': '504.12'}, {'value': '168.000', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '408.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'FG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)\n\nPen of SB5'}, {'id': 'BG001', 'title': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)\n\nPFS of SB5'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '10.58', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '11.41', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '10.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '177.63', 'spread': '7.753', 'groupId': 'BG000'}, {'value': '177.89', 'spread': '7.814', 'groupId': 'BG001'}, {'value': '177.76', 'spread': '7.764', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2014-12-22', 'resultsFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2014-12-26', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-06', 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose'}, {'measure': 'Maximum Serum Concentration (Cmax)', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Cmax (Tmax)', 'timeFrame': '0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '30464411', 'type': 'DERIVED', 'citation': 'Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018 Nov 5;12:3799-3805. doi: 10.2147/DDDT.S169082. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects\n* Have a body mass index between 20.0 to 29.9 kg/m², inclusive.\n\nExclusion Criteria:\n\n* History and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs\n* Active or latent Tuberculosis or who have a history of Tuberculosis\n* History of invasive systemic fungal infections or other opportunistic infections\n* Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process\n* Serious infection associated with hospitalisation and/or which required intravenous antibiotics\n* History of and/or current cardiac disease\n* Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the subject's last visit\n* Intake medication with a half-life \\> 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration"}, 'identificationModule': {'nctId': 'NCT02326233', 'briefTitle': 'Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samsung Bioepis Co., Ltd.'}, 'officialTitle': 'A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SB5-G12-NHV'}, 'secondaryIdInfos': [{'id': '2014-005178-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pen of SB5', 'description': 'Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)', 'interventionNames': ['Biological: Pen of SB5']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFS of SB5', 'description': 'PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)', 'interventionNames': ['Biological: PFS of SB5']}], 'interventions': [{'name': 'Pen of SB5', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Pen of SB5']}, {'name': 'PFS of SB5', 'type': 'BIOLOGICAL', 'armGroupLabels': ['PFS of SB5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Samsung Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Samsung Investigational Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Bioepis Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}