Viewing Study NCT01322594

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 1:39 AM

Ignite Modification Date: 2025-12-27 @ 11:57 PM

Study NCT ID: NCT01322594

Status: COMPLETED

Last Update Posted: 2013-10-23

First Post: 2011-03-23

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pipered@medimmune.com', 'phone': '+44 (0) 1223 471 471', 'title': 'Ed Piper', 'organization': 'MedImmune, Limited'}, '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. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Days 1-92', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MEDI2338 10 MG', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MEDI2338 30 MG', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MEDI2338 100 MG', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MEDI2338 300 MG', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MEDI2338 1000 MG', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing adverse events (includes both adverse events and serious adverse events)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Incidence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Significant Hematology Laboratory Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Significant Electrocardiogram Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Significant Vital Signs Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'PRIMARY', 'title': 'Incidence of Clinically Significant Serum Chemistry Laboratory Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Curve From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '27550.5', 'spread': '8163.6', 'groupId': 'OG000'}, {'value': '104751.1', 'spread': '40826.2', 'groupId': 'OG001'}, {'value': '281781.5', 'spread': '61554.1', 'groupId': 'OG002'}, {'value': '915668.6', 'spread': '342545.7', 'groupId': 'OG003'}, {'value': '3081728.5', 'spread': '846989.4', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Area under the serum concentration-time curve from time zerio to infinity of MEDI2338', 'unitOfMeasure': 'ng x day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '24427.8', 'spread': '8086.4', 'groupId': 'OG000'}, {'value': '87549.7', 'spread': '31391.2', 'groupId': 'OG001'}, {'value': '250155.6', 'spread': '40613.8', 'groupId': 'OG002'}, {'value': '846433.3', 'spread': '303849.8', 'groupId': 'OG003'}, {'value': '2909818.8', 'spread': '812729.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338', 'unitOfMeasure': 'ng x day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis'}, {'type': 'SECONDARY', 'title': 'Incidence of Anti-drug Antibodies (ADA) to MEDI2338', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 57, and 92', 'description': 'Number of participants with ADA to MEDI2338', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA'}, {'type': 'SECONDARY', 'title': 'Observed Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '2458.0', 'spread': '589.1', 'groupId': 'OG000'}, {'value': '9722.2', 'spread': '4376.8', 'groupId': 'OG001'}, {'value': '27122.6', 'spread': '2845.9', 'groupId': 'OG002'}, {'value': '106042.5', 'spread': '23883.9', 'groupId': 'OG003'}, {'value': '337004.5', 'spread': '51793.8', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Cmax of MEDI2338', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Elimination Phase Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '34.85', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '40.85', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '28.46', 'spread': '3.37', 'groupId': 'OG002'}, {'value': '26.76', 'spread': '5.54', 'groupId': 'OG003'}, {'value': '24.87', 'spread': '3.27', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 't1/2 of MEDI2338', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis'}, {'type': 'SECONDARY', 'title': 'Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG001', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG002', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG003', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG004', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'classes': [{'categories': [{'measurements': [{'value': '0.387', 'spread': '0.125', 'groupId': 'OG000'}, {'value': '0.312', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '0.365', 'spread': '0.071', 'groupId': 'OG002'}, {'value': '0.360', 'spread': '0.110', 'groupId': 'OG003'}, {'value': '0.346', 'spread': '0.097', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'CL of MEDI2338', 'unitOfMeasure': 'L/Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'FG001', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'FG002', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'FG003', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'FG004', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'FG005', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'RANDOMIZED SUBJECTS THROUGH STUDY DAY 240-300', 'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 31 participants provided written informed consent and participated in the study at 3 sites in South Africa (2 sites) and the United Kingdom (1 site) between 24Feb2011 and 25Nov2011.', 'preAssignmentDetails': 'Eligibile participants in the 10 and 30 mg dose groups received MEDI2338 in an open-label manner. Eligible participants in the 100, 300, and 1000 dose groups were randomized in a 3:1 ratio to receive MEDI2338 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG001', 'title': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG002', 'title': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG003', 'title': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG004', 'title': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG005', 'title': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '60.3', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '55.1', 'spread': '5.3', 'groupId': 'BG004'}, {'value': '60.8', 'spread': '6.0', 'groupId': 'BG005'}, {'value': '59.1', 'spread': '6.8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2011-03-23', 'resultsFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-09', 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing adverse events (includes both adverse events and serious adverse events)'}, {'measure': 'Incidence of Serious Adverse Events', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing serious adverse events'}, {'measure': 'Incidence of Clinically Significant Hematology Laboratory Results', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.'}, {'measure': 'Incidence of Clinically Significant Electrocardiogram Results', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.'}, {'measure': 'Incidence of Clinically Significant Vital Signs Results', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.'}, {'measure': 'Incidence of Clinically Significant Serum Chemistry Laboratory Results', 'timeFrame': 'Days 1 - 92', 'description': 'Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Concentration-Time Curve From Time Zero to Infinity', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Area under the serum concentration-time curve from time zerio to infinity of MEDI2338'}, {'measure': 'Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338'}, {'measure': 'Incidence of Anti-drug Antibodies (ADA) to MEDI2338', 'timeFrame': 'Days 1, 57, and 92', 'description': 'Number of participants with ADA to MEDI2338'}, {'measure': 'Observed Maximum Concentration (Cmax)', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'Cmax of MEDI2338'}, {'measure': 'Apparent Terminal Elimination Phase Half-life (t1/2)', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 't1/2 of MEDI2338'}, {'measure': 'Clearance (CL)', 'timeFrame': 'Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)', 'description': 'CL of MEDI2338'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Phase I study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI2338 in subjects with stable, mild to moderate chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 40 years at time of screening.\n* Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal.\n* Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial.\n* A diagnosis of mild to moderate COPD.\n* Cigarette smoking history of ≥10 pack years.\n* Ability to understand and comply with protocol requirements, instructions and restrictions.\n* COPD symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening.\n\nExclusion Criteria:\n\n* Current diagnosis of any respiratory condition other than COPD.\n* Active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study.\n* History of or suspected history of alcohol misuse or recreational substance abuse.\n* Treatment with oral or IV corticosteroids within 8 weeks prior to screening.\n* Concurrent enrolment in another clinical study.\n* Receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening.\n* Known history of allergy or reaction to any component of the investigational product.'}, 'identificationModule': {'nctId': 'NCT01322594', 'briefTitle': 'A Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1, Single Ascending Dose Study to Evaluate the Safety of MEDI2338 in Subjects With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CD-RI-MEDI2338-1033'}, 'secondaryIdInfos': [{'id': '2010-022879-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI2338 10 MG', 'description': 'MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Biological: MEDI2338']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI2338 30 MG', 'description': 'MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Biological: MEDI2338']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI2338 100 MG', 'description': 'MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Biological: MEDI2338']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI2338 300 MG', 'description': 'MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Biological: MEDI2338']}, {'type': 'EXPERIMENTAL', 'label': 'MEDI2338 1000 MG', 'description': 'MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Biological: MEDI2338']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'MEDI2338', 'type': 'BIOLOGICAL', 'description': 'MEDI2338 single intravenous (IV) dose (lowest dose)', 'armGroupLabels': ['MEDI2338 10 MG']}, {'name': 'MEDI2338', 'type': 'BIOLOGICAL', 'description': 'MEDI2338 single IV dose (next highest dose)', 'armGroupLabels': ['MEDI2338 30 MG']}, {'name': 'MEDI2338', 'type': 'BIOLOGICAL', 'description': 'MEDI2338 single IV dose (next highest dose)', 'armGroupLabels': ['MEDI2338 100 MG']}, {'name': 'MEDI2338', 'type': 'BIOLOGICAL', 'description': 'MEDI2338 single IV dose (next highest dose)', 'armGroupLabels': ['MEDI2338 300 MG']}, {'name': 'MEDI2338', 'type': 'BIOLOGICAL', 'description': 'MEDI2338 single IV dose (highest dose)', 'armGroupLabels': ['MEDI2338 1000 MG']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo single IV dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '6529', 'city': 'George', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'zip': '6045', 'city': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Edward Piper, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}