Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 6:14 AM
Study NCT ID:
NCT01202695
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'id': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601130', 'term': 'AVP-21D9'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessments', 'timeFrame': '90 days following infusion', 'description': 'Safety will be assessed by collecting data (physical exams, adverse event reporting, lab testing/analysis) and concomitant medications at each visit from pre-infusion period through post-infusion day 90 or the early withdrawl visit, if applicable.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) analysis', 'timeFrame': '90 days following infusion', 'description': 'PK parameters will be determined for a single intravenous administration of AVP-21D9 as measured by an immunoassay for AVP-21D9.'}, {'measure': 'Immunogenicity analysis', 'timeFrame': 'From day 1 up to day 90 following infusion', 'description': 'Immunogenicity will be measured by blood testing/analysis on anti-AVP-21D9 antibody generation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anthrax']}, 'referencesModule': {'references': [{'pmid': '24733473', 'type': 'DERIVED', 'citation': 'Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'Primary:\n\n• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo\n\nSecondary:\n\n* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9\n* To evaluate the immunogenicity of AVP-21D9', 'detailedDescription': 'This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy volunteers, between 18 and 45 years of age\n* Normal laboratory (blood test) results\n\nKey Exclusion Criteria:\n\n* Prior immunization with anthrax vaccine'}, 'identificationModule': {'nctId': 'NCT01202695', 'briefTitle': 'Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emergent BioSolutions'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EBS.AVP.001'}, 'secondaryIdInfos': [{'id': 'DMID 09-0008', 'type': 'OTHER_GRANT', 'domain': 'HHSN272200800040C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVP-21D9', 'interventionNames': ['Drug: AVP-21D9']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AVP-21D9', 'type': 'DRUG', 'description': 'intravenously, single dose', 'armGroupLabels': ['AVP-21D9']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo comparator'], 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Development Solutions', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert Hopkins, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emergent BioSolutions'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergent BioSolutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}