Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-30 @ 2:21 AM
Study NCT ID:
NCT04094857
Status:
UNKNOWN
Last Update Posted:
2019-10-07
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of HBN-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1', 'timeFrame': 'Initiation of TTM until a minimum of 72 hours', 'description': 'Safety and tolerability based on evaluation of adverse events, serious adverse events, physical examinations, vital signs measurements, electrocardiograms, and changes in clinical laboratory values (hematology, biochemistry, and urinalysis)'}], 'secondaryOutcomes': [{'measure': 'Determine the incidence of the need for implementation of treatment to offset shivering', 'timeFrame': 'Initiation of TTM until a minimum of 72 hours', 'description': 'Number and proportion of subjects who require intervention for shivering.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['therapeutic temperature management; therapeutic hypothermia'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest. HBN-1 will be administered IV as a loading dose infusion followed by a 12-hour maintenance infusion.', 'detailedDescription': 'Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest.\n\nHBN-1 will be administered as an IV solution according to a weight-based escalating loading dose infusion rate scheme involving three sequential cohorts with a loading dose of HBN 1 administered over 60 minutes (Cohort A), 45 minutes (Cohort B), or 30 minutes (Cohort C). For all cohorts, the loading dose will be followed by a 12-hour maintenance infusion of HBN-1.\n\nDosing cohorts will include a minimum of 6 subjects randomized in a 2:1 ratio of HBN-1 plus standard of care versus standard of care alone. Individual cohorts may be expanded to up to a maximum of 12 subjects . If the cohort is expanded, the additional subjects will receive HBN-1 + SOC.\n\nDuring the loading dose and maintenance infusion, physical exam, temperature, assessment of shivering, ECG, vital signs, clinical laboratory, blood alcohol level, and neurologic status will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40 to 80 years, inclusive\n2. Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity\n3. Return of spontaneous circulation within 50 minutes of the event\n4. FOUR Motor Score \\<4\n5. Maximum estimated weight not to exceed 100 kg\n\nExclusion Criteria:\n\n1. Return of spontaneous circulation \\>8 hours\n2. Known history of prior cardiac arrest, alcohol, or substance abuse or dependence\n3. Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis\n4. Comfort measures only or anticipated withdrawal of life-support within 24 hours\n5. Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons)\n6. Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score \\>2)\n7. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end-stage chronic illness with no reasonable expectation of survival to hospital discharge\n8. Is able to obey to verbal commands\n9. Is receiving IV vasopressin or lidocaine hydrochloride'}, 'identificationModule': {'nctId': 'NCT04094857', 'briefTitle': 'Phase 1 Study of HBN-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hibernaid, Inc'}, 'officialTitle': 'A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest', 'orgStudyIdInfo': {'id': 'HBN-1-001-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HBN-1 Plus Standard of Care', 'description': 'Subjects will receive an intravenous loading dose of HBN-1 followed by a 12 hour maintenance infusion plus standard of care targeted temperature management', 'interventionNames': ['Drug: HBN-1']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Subjects will receive standard of care targeted temperature management only'}], 'interventions': [{'name': 'HBN-1', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['HBN-1 Plus Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'contacts': [{'name': 'David B Seder, MD', 'role': 'CONTACT', 'email': 'sederd@mmc.org', 'phone': '207-662-2179'}], 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Adam Frisch, MD', 'role': 'CONTACT', 'email': 'frischan@upmc.edu', 'phone': '412-647-2345'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Eric Berrios', 'role': 'CONTACT', 'email': 'eric.berrios@pharpoint.com', 'phone': '919-433-2159'}, {'name': 'Ashtyn Neuwirth', 'role': 'CONTACT', 'email': 'ashtyn.neuwirth@pharpoint.com', 'phone': '919-433-2500'}], 'overallOfficials': [{'name': 'Laurence Katz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hibernaid, Inc'}, {'name': 'David B Seder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hibernaid, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}