Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-03 @ 6:31 AM
Study NCT ID:
NCT02955459
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707821', 'term': 'taniborbactam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-02', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.', 'timeFrame': 'Part 1: 8 days. Part 2: 17 days'}]}, 'conditionsModule': {'keywords': ['Healthy volunteers', 'Pharmacokinetics'], 'conditions': ['Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '34370573', 'type': 'DERIVED', 'citation': 'Dowell JA, Dickerson D, Henkel T. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous beta-Lactamase Inhibitor. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0105321. doi: 10.1128/AAC.01053-21. Epub 2021 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Males or non-pregnant, non-lactating females\n* Body Mass Index (BMI) between 18.5 - 32.0, inclusive.\n* Suitable veins for cannulation\n\nExclusion Criteria:\n\n* Employee of site or the sponsor\n* Any disease that poses an unacceptable risk to participants\n* Abnormal ECG\n* Abnormal labs\n* Abnormal vital signs\n* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder\n* Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1\n* Current smokers or history of smoking within 30 days'}, 'identificationModule': {'nctId': 'NCT02955459', 'briefTitle': 'VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venatorx Pharmaceuticals, Inc.'}, 'officialTitle': 'VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'VNRX-5133-101/102'}, 'secondaryIdInfos': [{'id': 'DMID 16-0014', 'type': 'OTHER', 'domain': 'DMID'}, {'id': '272201300019C-3-0-1', 'link': 'https://reporter.nih.gov/quickSearch/272201300019C-3-0-1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VNRX-5133', 'description': 'IV infusion', 'interventionNames': ['Drug: VNRX-5133']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VNRX-5133', 'type': 'DRUG', 'armGroupLabels': ['VNRX-5133']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venatorx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}