Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-30 @ 5:58 PM
Study NCT ID:
NCT01922661
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-09', 'studyFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2013-08-12', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'day 1 to day 113', 'description': 'The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).'}], 'secondaryOutcomes': [{'measure': 'Serum concentration', 'timeFrame': 'day 1 to day 113', 'description': 'The secondary endpoint is serum concentrations of REGN1908-1909 over time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'referencesModule': {'references': [{'pmid': '34437752', 'type': 'DERIVED', 'citation': 'Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy men and women between the ages of 18 and 55\n2. Positive allergen skin prick test\n3. Willing and able to comply with clinic visits and study-related procedures\n4. Provide signed informed consent\n\nExclusion Criteria:\n\n1. Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit\n2. Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination\n3. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial\n4. Hospitalization for any reason within 60 days prior to the screening visit\n5. 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\n6. Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results\n\nThe information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed."}, 'identificationModule': {'nctId': 'NCT01922661', 'briefTitle': 'Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R1908-HV-1240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Dose 1 of REGN1908-1909 or placebo', 'interventionNames': ['Drug: REGN1908-1909', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Dose 2 of REGN1908-1909 or placebo', 'interventionNames': ['Drug: REGN1908-1909', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Dose 3 of REGN1908-1909 or placebo', 'interventionNames': ['Drug: REGN1908-1909', 'Other: placebo']}], 'interventions': [{'name': 'REGN1908-1909', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}