Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT03046459
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study of BNZ132-1-40
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects with related, treatment-emergent adverse events', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'PK: Exposure as determined by maximum plasma concentration (Cmax)', 'timeFrame': '1 Day'}, {'measure': 'PK: Exposure as determined by area under the concentration-time curve (AUC)', 'timeFrame': '30 days'}, {'measure': 'PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cytokines', 'interleukin-2', 'Safety Issues'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26183780', 'type': 'BACKGROUND', 'citation': 'Nata T, Basheer A, Cocchi F, van Besien R, Massoud R, Jacobson S, Azimi N, Tagaya Y. Targeting the binding interface on a shared receptor subunit of a cytokine family enables the inhibition of multiple member cytokines with selectable target spectrum. J Biol Chem. 2015 Sep 11;290(37):22338-51. doi: 10.1074/jbc.M115.661074. Epub 2015 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.', 'detailedDescription': 'This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and non-pregnant, non-lactating females\n* no ongoing clinically significant medical condition\n* willing and able to provide informed consent\n* no use of Rx or OTC medications, other than oral contraceptives\n\nExclusion Criteria:\n\n* Recent systemic infections\n* Clinically-significant abnormal clinical labs, ECG or physical examination\n* Immunization 30 days prior to study'}, 'identificationModule': {'nctId': 'NCT03046459', 'briefTitle': 'A First-in-Human Study of BNZ132-1-40', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioniz Therapeutics'}, 'officialTitle': 'A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40', 'orgStudyIdInfo': {'id': 'BNZ-CT-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BNZ132-1-40', 'description': 'a range of IV doses', 'interventionNames': ['Biological: BNZ132-1-40']}], 'interventions': [{'name': 'BNZ132-1-40', 'type': 'BIOLOGICAL', 'description': 'pegylated peptide inhibiting IL-2, IL-9 and IL-15', 'armGroupLabels': ['BNZ132-1-40']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Paul A Frohna, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bioniz Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioniz Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Celerion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}