Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 6:12 PM
Study NCT ID:
NCT03070561
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2017-02-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label, crossover, local pharmacokinetics study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement', 'timeFrame': '3 days'}, {'measure': 'Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement', 'timeFrame': '3 days'}, {'measure': 'Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peanut Allergy', 'Immunotherapy', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children', 'detailedDescription': 'In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 3 years and \\<30 years.\n* Able to give informed consent.\n* English speaking with no language impairment\n* Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months\n\nExclusion Criteria:\n\n* History of reaction to peanuts\n* Major active medical problems of the oral cavity or use of medications that might change rates of salivation'}, 'identificationModule': {'nctId': 'NCT03070561', 'briefTitle': 'Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects', 'orgStudyIdInfo': {'id': 'JHU NA_00072576'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sublingual film with peanut extract', 'interventionNames': ['Biological: sublingual film with peanut extract']}], 'interventions': [{'name': 'sublingual film with peanut extract', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Sublingual film with peanut extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Corinne Keet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}