Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00353756
Status:
UNKNOWN
Last Update Posted:
2006-10-11
First Post:
2006-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-09'}, 'lastUpdateSubmitDate': '2006-10-10', 'studyFirstSubmitDate': '2006-07-17', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluations'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics'}, {'measure': 'Biomarker changes -- IL-6, CRP and other acute phase reactants'}, {'measure': "Crohn's Disease Activity Index (CDAI)"}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.", 'detailedDescription': "Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine:\n\n* pharmacokinetics (change in serum concentrations over time),\n* biological activity (change in blood markers relecting activity of Crohn's Disease),\n* effects on symptoms of Crohn's disease.\n\nParticipants may receive either a single or several intravenous infusions of C326 or matching placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18 - 65\n* Stable, moderately active Crohn's Disease\n* Otherwise in generally good health\n\nExclusion Criteria:\n\n* Variety of concurrent medical conditions\n* Various concomitant medications"}, 'identificationModule': {'nctId': 'NCT00353756', 'briefTitle': "Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Avidia'}, 'officialTitle': "A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn's Disease", 'orgStudyIdInfo': {'id': 'AV14-C001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'C326, IL-6 Inhibitory Avimer protein', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Graham Radford-Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'QPharm', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Lee Min Yap, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Clinical Studies', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Gabrielle McKee', 'role': 'CONTACT', 'email': 'Gabrielle.McKee@clinetserv.com', 'phone': '61 (0)7 3331 3933'}], 'overallOfficials': [{'name': 'Lee Min Yap, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfred Hospital, Melbourne, Australia'}, {'name': 'Graham Radford-Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Brisbane and Womens Hospital, Brisbane, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avidia', 'class': 'INDUSTRY'}}}}