Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-27 @ 1:17 PM
Study NCT ID:
NCT05738993
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C485206', 'term': 'pertuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-∞', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'Area under the concentration-time curve of the drug over the time interval from zero to infinity'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'maximum observed plasma concentration of the drug'}, {'measure': 'Tmax', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'time from administration to maximum observed plasma concentration of the drug'}, {'measure': 'T½', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'Elimination half-life'}, {'measure': 'Kel', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'elimination rate constant'}, {'measure': 'CL', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'total clearance'}, {'measure': 'Vd', 'timeFrame': 'pre-dose to day 91, 23 timepoints', 'description': 'volume of distribution'}, {'measure': 'safety assessment', 'timeFrame': 'Day 1 to day 91', 'description': 'frequency, severity, and profile of adverse events'}, {'measure': 'immunogenicity assessment', 'timeFrame': 'pre-dose to day 91, 5 timepoints', 'description': 'binding anti-drug antibodies (BAb) and neutralizing anti-drug antibodies (NAb)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent;\n* Men aged 18-45 years;\n* Body mass index (BMI) in the range of 18.5 30.0 kg/m2;\n* The confirmed "healthy" status;\n* Left ventricular ejection fraction (LVEF) \\> 50 % based on the results of EchoCG at screening;\n* Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;\n\nExclusion Criteria:\n\n* Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;\n* Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;\n* History or evidence of any chronic disease'}, 'identificationModule': {'nctId': 'NCT05738993', 'briefTitle': 'A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BCD-178-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-178 group', 'description': 'single IV infusion of BCD-178 at a dose of 420 mg', 'interventionNames': ['Drug: BCD-178']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Perjeta Group', 'description': 'single IV infusion of Perjeta at a dose of 420 mg', 'interventionNames': ['Drug: Perjeta']}], 'interventions': [{'name': 'BCD-178', 'type': 'DRUG', 'otherNames': ['pertuzumab'], 'description': 'A single intravenous (IV) infusion at a dose of 420 mg', 'armGroupLabels': ['BCD-178 group']}, {'name': 'Perjeta', 'type': 'DRUG', 'otherNames': ['pertuzumab'], 'description': 'A single intravenous (IV) infusion at a dose of 420 mg', 'armGroupLabels': ['Perjeta Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '192177', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Polyclinic №77', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194214', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'X7 Clinical Research', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}