Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT01258205
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2010-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600954', 'term': 'AMG 139'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2010-12-09', 'studyFirstSubmitQcDate': '2010-12-09', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amgen', 'AMG 139', "Crohn's Disease"], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the safety and tolerability of AMG 139 following multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in subjects with mild to severe Crohn's disease (CD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPart A - Healthy Subjects:\n\n* Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age\n* Body mass index (BMI) between 18 and 32 kg/m2\n* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG\n* Additional inclusion criteria apply\n\nPart B - Crohn's Subjects:\n\n* Male or female subjects with CD between 18 to 55 years-of-age\n* Body mass index (BMI) between 18 and 32 kg/m2\n* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of mild to severe CD\n* Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months\n* Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to or greater than 180 and equal to or less than 450\n* Elevated fecal calprotectin and CRP\n* Additional inclusion criteria apply\n\nExclusion Criteria:\n\nParts A - Healthy Subjects:\n\n* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;\n* Recent or on-going infection(s)\n* Underlying condition(s) that predisposes the subject to infections\n* History of malignancy of any type\n* Additional exclusion criteria apply\n\nPart B only - Crohn's Subjects:\n\n* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;\n* Recent or on-going infection(s)\n* Underlying condition(s) that predisposes the subject to infections\n* History of malignancy of any type\n* Additional exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT01258205', 'briefTitle': "Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease", 'orgStudyIdInfo': {'id': '20090519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': "One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.", 'interventionNames': ['Drug: AMG 139']}, {'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.', 'interventionNames': ['Drug: AMG 139']}], 'interventions': [{'name': 'AMG 139', 'type': 'DRUG', 'description': "Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).", 'armGroupLabels': ['Part A', 'Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Comprehensive Clinical Research', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '23291', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'QPharm Pty Limited', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Clinical Medical and Analytical eXellence CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3181', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Clinical Studies (Alfred)', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}