Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00688012
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2008-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of SPC3649 in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581159', 'term': 'miravirsen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2008-05-07', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antisense', 'microRna antagonist', 'anti-miR-122', 'Safety in healthy volunteers', 'Hepatitis C'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* BMI: 19-28 kg/m2\n* No clinically significant disease/disorder\n* Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion\n* Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.\n\nExclusion Criteria:\n\n* Heavy exercise within the past 7 days\n* Alcohol intake\\> 21 units weekly\n* Regular smoker\n* Received experimental drug within 30 days of study entry\n* Planned participation in any experimental study during the study period\n* HIV-Ab, HBsAg and/or HCV Ab positive\n* History of specific allergy\n* Current use of any drug or narcotics.'}, 'identificationModule': {'nctId': 'NCT00688012', 'briefTitle': 'Safety Study of SPC3649 in Healthy Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santaris Pharma A/S'}, 'officialTitle': 'A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649', 'orgStudyIdInfo': {'id': 'SPC3649-201'}, 'secondaryIdInfos': [{'id': 'EudraCT nummer 2008-001012-20'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SPC3649', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'PhaseOne Trials, Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santaris Pharma A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Joan Drejer/Regulatory Manager', 'oldOrganization': 'Santaris Pharma'}}}}