Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 12:31 PM
Study NCT ID:
NCT03282851
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 696}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}], 'secondaryOutcomes': [{'measure': 'Area Under Curve From Tme Zero to 72 Hours After Dosing (AUC 0-72) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Percentage of Area Under Curve From Zero to Infinity (AUC0-∞) Obtained by Extrapolation (AUC extra%) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Time To Reach Maximum Serum Concentration (tmax) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Time to Last Observed Serum Concentration (tlast) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Apparent Terminal Rate Constant (λz) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Apparent Terminal Half-life (t½) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Apparent Total Body Clearance of Drug from Serum Following Subcutaneous Administration (CL/F) of MSB11456, US-licensed Actemra, and EU-approved RoActemra', 'timeFrame': 'Up to Day 48'}, {'measure': 'Safety Profile as Assessed by Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Injection Site Reactions, Laboratory Variables, Vital Signs and Electrocardiogram (ECG) Measurements', 'timeFrame': 'Up to Day 48'}, {'measure': 'Immunogenicity as Assessed by Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies (NABs)', 'timeFrame': 'Up to Day 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSB11456', 'Actemra®', 'RoActemra®'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects, 18 to 55 years of age, with a body mass index (BMI) between 18 and 29.9 kilogram per meter square (kg/m\\^2).\n* Subjects who are on adequate contraception as defined in the protocol and are willing and able to comply with the scheduled study visits, Investigational medicinal product (IMP) administration, safety laboratory tests, and all other study procedures.\n* Other protocol defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Subjects with history and/or current presence of clinically significant atopic allergy (for example, asthma including childhood asthma, urticaria, angio-edema, eczematous dermatitis).\n* Subjects with hypersensitivity or allergic reactions, including known or suspected clinically relevant drug hypersensitivity to any components of the IMP formulations, comparable drugs, or to latex.\n* Subjects who have active or latent tuberculosis as indicated by a positive QuantiFERON®-Tuberculosis (TB) Gold test or a history of tuberculosis, lifetime history of invasive systemic fungal infections (for example, histoplasmosis) or other opportunistic infections, including recurrent or chronic local fungal infections, frequent (more than 3 per year requiring treatment) chronic or recurrent infections, having previously been treated with tocilizumab or taken a recombinant monoclonal antibody.\n* Subjects who have received a live vaccine within 12 weeks before enrolling in this study or planning for any such vaccination during the study or within 4 months after IMP administration.\n* Other protocol defined exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT03282851', 'briefTitle': 'Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi SwissBioSim GmbH'}, 'officialTitle': 'Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability and Immunogenicity of MSB11456, US-licensed Actemra® and EU-approved RoActemra® in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'MS200740-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSB11456', 'interventionNames': ['Drug: MSB11456']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US-licensed Actemra', 'interventionNames': ['Drug: US-licensed Actemra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-approved RoActemra', 'interventionNames': ['Drug: EU-approved RoActemra']}], 'interventions': [{'name': 'MSB11456', 'type': 'DRUG', 'description': 'Subjects will receive a single injection of MSB11456 on Day 1.', 'armGroupLabels': ['MSB11456']}, {'name': 'US-licensed Actemra', 'type': 'DRUG', 'description': 'Subjects will receive a single injection of US-licensed actemra on Day 1.', 'armGroupLabels': ['US-licensed Actemra']}, {'name': 'EU-approved RoActemra', 'type': 'DRUG', 'description': 'Subjects will receive a single injection of EU-approved RoActemra on Day 1.', 'armGroupLabels': ['EU-approved RoActemra']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Research site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fresenius Kabi SwissBioSim GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi SwissBioSim GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}