Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-17 @ 11:06 PM
Study NCT ID:
NCT00116168
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542276', 'term': 'enokizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raibleD@medimmune.com', 'phone': '301-398-0000', 'title': 'Don Raible, MD', 'organization': 'MedImmune'}, 'certainAgreement': {'otherDetails': 'MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Days 0-84', 'description': 'No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.', 'eventGroups': [{'id': 'EG000', 'title': 'MEDI-528 0.3 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MEDI-528 1 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI-528 3 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MEDI-528 9 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood chloride increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Lymph node palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 84', 'description': 'Number of participants experiencing adverse events (includes both 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administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 1, 7, 14, and 28', 'description': 'Number of participants with troponin levels greater than upper limit of normal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Significant Changes From Baseline in Neurologic Exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 7, 14, 21, 28, 42, and 84', 'description': 'Number of participants with clinically significant changes from baseline in neurologic exam', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)'}, {'type': 'PRIMARY', 'title': 'Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 and 28', 'description': 'Number of participants with changes from baseline in the Day 28 MRI of the brain', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)'}, {'type': 'PRIMARY', 'title': 'Incidence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 - 84', 'description': 'Number of participants experiencing serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)'}, {'type': 'SECONDARY', 'title': 'Incidence of Anti-drug Antibodies (ADA) to MEDI-528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0, 14, 28, 42, and 84', 'description': 'Number of participants with ADA to MEDI-528', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)'}, {'type': 'SECONDARY', 'title': 'Time to Observed Maximum Serum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '5.51', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '4.50', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '1.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Tmax of MEDI-528', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '14.48', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '23.00', 'spread': '5.62', 'groupId': 'OG002'}, {'value': '82.50', 'spread': '19.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Cmax of MEDI-528', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '18.47', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '329.7', 'spread': '113.72', 'groupId': 'OG001'}, {'value': '923.27', 'spread': '226.71', 'groupId': 'OG002'}, {'value': '3053.34', 'spread': '908.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(0-t) of MEDI-528', 'unitOfMeasure': 'Micrograms times day per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '40.78', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '667.68', 'spread': '201.99', 'groupId': 'OG001'}, {'value': '1287.31', 'spread': '413.92', 'groupId': 'OG002'}, {'value': '3770.06', 'spread': '1396.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(0-infinity) of MEDI-528', 'unitOfMeasure': 'Microgram times day per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '33.32', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '50.90', 'spread': '13.82', 'groupId': 'OG001'}, {'value': '26.05', 'spread': '9.16', 'groupId': 'OG002'}, {'value': '16.61', 'spread': '8.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(ext) of MEDI-528', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Total Body Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.49', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '0.20', 'spread': '0.09', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'CL of MEDI-528', 'unitOfMeasure': 'Liter per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '6.47', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '86.85', 'spread': '19.86', 'groupId': 'OG001'}, {'value': '44.43', 'spread': '11.48', 'groupId': 'OG002'}, {'value': '33.44', 'spread': '11.32', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'T1/2 of MEDI-528', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}, {'type': 'SECONDARY', 'title': 'Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose'}, {'id': 'OG001', 'title': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose'}, {'id': 'OG002', 'title': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose'}, {'id': 'OG003', 'title': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose'}], 'classes': [{'categories': [{'measurements': [{'value': '4.58', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '14.57', 'spread': '8.61', 'groupId': 'OG001'}, {'value': '10.91', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '8.65', 'spread': '1.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Vz/F of MEDI-528', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MEDI-528 0.3 mg'}, {'id': 'FG001', 'title': 'MEDI-528 1 mg'}, {'id': 'FG002', 'title': 'MEDI-528 3 mg'}, {'id': 'FG003', 'title': 'MEDI-528 9 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 29 participants provided written informed consent and participated in the study at 2 sites in the United States of America between 10Jun2005 and 18Apr2006.', 'preAssignmentDetails': 'Eligible participants received MEDI-528 in an open-label manner.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MEDI-528 0.3 mg'}, {'id': 'BG001', 'title': 'MEDI-528 1 mg'}, {'id': 'BG002', 'title': 'MEDI-528 3 mg'}, {'id': 'BG003', 'title': 'MEDI-528 9 mg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '33.2', 'spread': '13.9', 'groupId': 'BG003'}, {'value': '29.2', 'spread': '10.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-17', 'studyFirstSubmitDate': '2005-06-27', 'resultsFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2005-06-27', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-17', 'studyFirstPostDateStruct': {'date': '2005-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Days 0 - 84', 'description': 'Number of participants experiencing adverse events (includes both adverse events and serious adverse events)'}, {'measure': 'Incidence of Abnormal Troponin Levels', 'timeFrame': 'Days 0, 1, 7, 14, and 28', 'description': 'Number of participants with troponin levels greater than upper limit of normal'}, {'measure': 'Incidence of Clinically Significant Changes From Baseline in Neurologic Exam', 'timeFrame': 'Days 0, 7, 14, 21, 28, 42, and 84', 'description': 'Number of participants with clinically significant changes from baseline in neurologic exam'}, {'measure': 'Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain', 'timeFrame': 'Days 0 and 28', 'description': 'Number of participants with changes from baseline in the Day 28 MRI of the brain'}, {'measure': 'Incidence of Serious Adverse Events', 'timeFrame': 'Days 0 - 84', 'description': 'Number of participants experiencing serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Incidence of Anti-drug Antibodies (ADA) to MEDI-528', 'timeFrame': 'Days 0, 14, 28, 42, and 84', 'description': 'Number of participants with ADA to MEDI-528'}, {'measure': 'Time to Observed Maximum Serum Concentration (Tmax)', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Tmax of MEDI-528'}, {'measure': 'Observed Maximum Serum Concentration (Cmax)', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Cmax of MEDI-528'}, {'measure': 'Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(0-t) of MEDI-528'}, {'measure': 'Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(0-infinity) of MEDI-528'}, {'measure': 'Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'AUC(ext) of MEDI-528'}, {'measure': 'Total Body Clearance (CL)', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'CL of MEDI-528'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'T1/2 of MEDI-528'}, {'measure': 'Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)', 'timeFrame': 'Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84', 'description': 'Vz/F of MEDI-528'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19446146', 'type': 'DERIVED', 'citation': 'White B, Leon F, White W, Robbie G. Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers. Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.'}]}, 'descriptionModule': {'briefSummary': 'A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.', 'detailedDescription': 'The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug\n* Weight less than 89 kg\n* Written informed consent obtained from the volunteer\n* Healthy by medical history and physical examination\n* Sexually active females, unless surgically sterile or at least two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day 84 after their dose of study drug.\n* Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of the study results.\n* Ability to complete the follow-up period of 84 days\n* Willing to forego other forms of experimental treatment during the study period of 84 days\n* Willing to forego vigorous activity 1 - 2 days before dosing, and before each study visit.\n\nExclusion Criteria:\n\n* Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study\n* Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0\n* Any blood donation or significant loss of blood within 6 months of time of entry into the study\n* History of immunodeficiency or receipt of immunosuppressive drugs\n* History of allergy or reaction to any component of the MEDI-528 formulation\n* History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period\n* Evidence of any systemic disease, neurologic abnormality, lymphadenopathy, or splenomegaly upon physical examination\n* Evidence of infection with hepatitis A, B, or C virus or HIV-1\n* Receipt of immunoglobulins or blood products within 60 days of entering the study\n* Receipt of any investigational drug therapy or standard vaccine therapy, other than vaccination for influenza, within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)\n* Receipt of MEDI-528 in any previous clinical study\n* At Screening (must be within 21 days before study dose administration) any of the following: Hgb, total WBC, platelet count, Na, K, C1, CO2, AST, ALT, BUN, glucose, amylase, lipase, creatinine, or troponin out of the normal range; other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator, are judged to be clinically significant\n* Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening\n* Clinically significant abnormalities noted on baseline brain MRI\n* Elective surgery planned during the study period through Study Day 84\n* Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of study drug, before dosing)\n* Nursing mother\n* The presence of any condition or concern which, in the opinion of the investigator, may interfere with the conduct or interpretation of the study."}, 'identificationModule': {'nctId': 'NCT00116168', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'MI-CP109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI-528 0.3 mg/kg', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose', 'interventionNames': ['Biological: MEDI-528 0.3 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-528 1 mg/kg', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose', 'interventionNames': ['Biological: MEDI-528 1 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-528 3 mg/kg', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose', 'interventionNames': ['Biological: MEDI-528 3 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI-528 9 mg/kg', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose', 'interventionNames': ['Biological: MEDI-528 9 mg/kg']}], 'interventions': [{'name': 'MEDI-528 0.3 mg/kg', 'type': 'BIOLOGICAL', 'description': 'MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose', 'armGroupLabels': ['MEDI-528 0.3 mg/kg']}, {'name': 'MEDI-528 1 mg/kg', 'type': 'BIOLOGICAL', 'description': 'MEDI-528 (1 mg/kg) administered as a single, SC dose', 'armGroupLabels': ['MEDI-528 1 mg/kg']}, {'name': 'MEDI-528 3 mg/kg', 'type': 'BIOLOGICAL', 'description': 'MEDI-528 (3 mg/kg) administered as a single, SC dose', 'armGroupLabels': ['MEDI-528 3 mg/kg']}, {'name': 'MEDI-528 9 mg/kg', 'type': 'BIOLOGICAL', 'description': 'MEDI-528 (9 mg/kg) administered as a single, SC dose', 'armGroupLabels': ['MEDI-528 9 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MDS Pharma Services', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'MDS Pharma Services', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Barbara White, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}