Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-01 @ 1:29 PM
Study NCT ID:
NCT02673567
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma drug concentration (Cmax)', 'timeFrame': '33 weeks'}, {'measure': 'Time to maximum observed plasma drug concentration (tmax)', 'timeFrame': '33 weeks'}, {'measure': 'AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)', 'timeFrame': '33 weeks'}, {'measure': 'AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)', 'timeFrame': '33 weeks'}, {'measure': 'AUC from time 0 extrapolated to infinity (AUC0-∞)', 'timeFrame': '33 weeks'}, {'measure': 'Percentage extrapolated AUC (%AUCext)', 'timeFrame': '33 weeks'}, {'measure': 'Apparent serum terminal elimination rate constant (λz)', 'timeFrame': '33 weeks'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': '33 weeks'}, {'measure': 'Apparent volume of distribution during the terminal phase (Vz/F)', 'timeFrame': '33 weeks'}, {'measure': 'Apparent serum terminal elimination half-life (t½)', 'timeFrame': '33 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Adverse Events', 'timeFrame': '33 weeks'}, {'measure': 'Tolerability- Percentage of participants who fail to complete the study', 'timeFrame': '33 weeks'}, {'measure': 'Percentage of participants who fail to complete the study due to adverse events', 'timeFrame': '33 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is a man or woman, 18 to 55 years of age, inclusive\n* The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive\n* The subjects must be in a good health at screening and check-in\n\nAdditional inclusion criteria for Japanese subjects:\n\n* Subject must be a non-naturalized Japanese citizen and hold a Japanese passport\n* Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens\n* Subject has been living outside of Japan for no more than 10 years\n\nAdditional inclusion criteria for Caucasian subjects:\n\n* The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.\n\n * Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* The subject is a woman who is pregnant or lactating\n* The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)\n* The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment\n* Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing\n\n * Additional criteria apply, please contact the investigator for more information'}, 'identificationModule': {'nctId': 'NCT02673567', 'briefTitle': 'To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects', 'orgStudyIdInfo': {'id': 'TV48125-PK-10078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TEV-48125 - 1', 'description': 'Dose Regimen 1', 'interventionNames': ['Drug: TEV-48125 - 1']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 - 2', 'description': 'Dose Regimen 2', 'interventionNames': ['Drug: TEV-48125 - 2']}, {'type': 'EXPERIMENTAL', 'label': 'TEV-48125 - 3', 'description': 'Dose Regimen 3', 'interventionNames': ['Drug: TEV-48125 - 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TEV-48125 - 1', 'type': 'DRUG', 'otherNames': ['monoclonal antibody'], 'description': 'Subcutaneous administration Dose Regimen 1', 'armGroupLabels': ['TEV-48125 - 1']}, {'name': 'TEV-48125 - 2', 'type': 'DRUG', 'otherNames': ['monoclonal antibody'], 'description': 'Subcutaneous administration Dose Regimen 2', 'armGroupLabels': ['TEV-48125 - 2']}, {'name': 'TEV-48125 - 3', 'type': 'DRUG', 'otherNames': ['monoclonal antibody'], 'description': 'Subcutaneous administration Dose Regimen 3', 'armGroupLabels': ['TEV-48125 - 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13529', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}