Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-04-18 @ 8:33 AM
Study NCT ID:
NCT02083666
Status:
TERMINATED
Last Update Posted:
2015-07-28
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Transient adverse events observed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-03-10', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration', 'timeFrame': 'Up to 13 weeks', 'description': 'Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables.'}], 'secondaryOutcomes': [{'measure': 'Assessment of pharmacokinetics of SOBI002 through analysis of serum samples', 'timeFrame': 'Up to 13 weeks'}, {'measure': 'Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity', 'timeFrame': 'Up to 13 weeks'}, {'measure': 'Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies', 'timeFrame': 'Up to 13 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Dose cohorts', 'Escalating dose', 'Single dose', 'Multiple dose', 'Safety', 'Tolerability', 'Pharmacokinetics', 'Pharmacodynamics', 'volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.', 'detailedDescription': 'This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.\n\nEligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females of non-childbearing potential or males\n* 18 to 45 years of age\n* Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.\n\nExclusion Criteria:\n\n* Females of childbearing potential\n* Clinically significant disease\n* Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.'}, 'identificationModule': {'nctId': 'NCT02083666', 'briefTitle': 'Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'SOBI002-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOBI002', 'description': 'Single and repeated administration of different doses of test product', 'interventionNames': ['Drug: SOBI002']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Single and repeated administration of placebo comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SOBI002', 'type': 'DRUG', 'description': 'Test Product', 'armGroupLabels': ['SOBI002']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Reference product', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0RE', 'city': 'London', 'state': "Saint George's University of London", 'country': 'United Kingdom', 'facility': 'Richmond Pharmacology Ltd.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Erik Brouwer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swedish Orphan Biovitrum AB (publ)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Richmond Pharmacology Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}