Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT00868660
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2009-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and tolerability', 'timeFrame': 'January2009-January2010'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Jan 2009 - Jan 2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': "Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose", 'detailedDescription': "A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult male and/or females, 18 to 50 years of age\n* Body mass index (BMI)18-30. Chrons Inclusion\n* Adult male and/or females, 18 to 60 years of age (inclusive).\n* Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).\n* Crohn's Disease Activity Index (CDAI) score \\< 150.\n* In a stable state of Crohn's disease as per the Investigator's opinion.\n* Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.\n\nExclusion Criteria:\n\n* History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.\n* Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT00868660', 'briefTitle': "Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose", 'nctIdAliases': ['NCT01429922'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Zealand Pharma'}, 'officialTitle': "A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission", 'orgStudyIdInfo': {'id': 'ZP08-216'}, 'secondaryIdInfos': [{'id': 'AA75468'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZP1848', 'description': "Healthy Subjects or Crohn's Disease patients", 'interventionNames': ['Drug: ZP1848']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Healthy subjects or Crohn's Disease patients", 'interventionNames': ['Drug: ZP1848']}], 'interventions': [{'name': 'ZP1848', 'type': 'DRUG', 'description': 'sc. bolus', 'armGroupLabels': ['Placebo', 'ZP1848']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08046', 'city': 'Willingboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CRI Worldwide', 'geoPoint': {'lat': 40.02789, 'lon': -74.86905}}], 'overallOfficials': [{'name': 'Christian Thorkildsen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zealand Pharma A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Christian Thorkildsen, Project Director', 'oldOrganization': 'Zealand Pharma A/S'}}}}