Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01209793
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2010-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2010-09-24', 'studyFirstSubmitQcDate': '2010-09-24', 'lastUpdatePostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events', 'timeFrame': 'Baseline through end of study'}], 'secondaryOutcomes': [{'measure': 'PK profile', 'timeFrame': 'Baseline through end of study'}, {'measure': 'Immunogenicity', 'timeFrame': 'Visits 2, 8, 10 and 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile\n* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive\n* Normal vital signs after resting in a sitting position for 5 minutes:\n* Normal standard 12-lead ECG\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide signed informed consent\n* Able to understand and complete study-related questionnaires\n\nExclusion Criteria:\n\n* Current or prior history of smoking\n* Any illness or condition that would adversely affect the subject's participation in this study\n* Hospitalization within 60 days of the screening visit\n* Any clinically significant abnormalities observed during the screening visit\n* History of or positive human immunodeficiency virus (HIV) screen result at the screening visit\n* History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit\n* History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit\n* Known sensitivity to any of the components of the Investigational Product formulation\n* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit\n* Any condition that would place the subject at risk, interfere with participation in the study\n* History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area\n* Live/attenuated vaccinations within 12 weeks of screening or during the study\n* Any subjects with planned elective surgery\n* Sexually active men who are unwilling to utilize adequate contraception"}, 'identificationModule': {'nctId': 'NCT01209793', 'briefTitle': 'Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'R846-HV-1007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': '(3:1, active: placebo)', 'interventionNames': ['Biological: REGN846']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': '(3:1, active: placebo)', 'interventionNames': ['Biological: REGN846']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': '(3:1, active: placebo)', 'interventionNames': ['Biological: REGN846']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4', 'description': '(3:1, active: placebo)', 'interventionNames': ['Biological: REGN846']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 5', 'description': '(3:1, active: placebo)', 'interventionNames': ['Biological: REGN846']}], 'interventions': [{'name': 'REGN846', 'type': 'BIOLOGICAL', 'description': '5 IV cohorts (Dose 1, 2, 3, 4, 5)', 'armGroupLabels': ['Dose 1', 'Dose 2', 'Dose 3', 'Dose 4', 'Dose 5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}