Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03494712
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2018-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessed by incidence of Adverse Events', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Safety criterion'}], 'secondaryOutcomes': [{'measure': 'The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)', 'description': 'Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples'}, {'measure': 'The PK profile of S 95010 plasma concentration : Plasma half-life', 'timeFrame': 'During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)', 'description': 'Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples'}, {'measure': 'The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)', 'timeFrame': 'During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12)', 'description': 'Safety and pharmacokinetic criteria - S 95010 (active parent compound) and its metabolites (if applicable) concentration in serial plasma and urinary samples'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['healthy volunteer', 'antimiR', 'single ascending dose'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'availIpds': [{'url': 'https://clinicaltrials.servier.com/', 'type': 'Individual Participant Data Set'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Study Protocol'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Statistical Analysis Plan'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Informed Consent Form'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Clinical Study Report'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'study-level clinical trial data'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young healthy male subjects aged between 18 and 45 years (both inclusive)\n\nExclusion Criteria:\n\n* Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations\n* Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator\n* History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT \\> ULN at selection\n* History of renal dysfunction or GFR \\< 75mL/min/1.73 m2 (MDRD equation) at selection'}, 'identificationModule': {'nctId': 'NCT03494712', 'briefTitle': 'Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.', 'orgStudyIdInfo': {'id': 'CL1-95010-001'}, 'secondaryIdInfos': [{'id': '2017-004180-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S 95010', 'description': 'Increasing single doses of S 95010 to 5 subjects.', 'interventionNames': ['Drug: S 95010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Increasing single doses of Placebo to 2 subjects.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'S 95010', 'type': 'DRUG', 'description': 'Single administration of S 95010 in healthy volunteers', 'armGroupLabels': ['S 95010']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Single administration of placebo in healthy volunteers', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Clinical Pharmacology Unit - Stuivenberg Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}]}, 'ipdSharingStatementModule': {'url': 'https://clinicaltrials.servier.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After Marketing Authorisation in EEA or US if the study is used for the approval.', 'ipdSharing': 'YES', 'description': 'Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).\n\nThey can ask all interventional clinical studies:\n\n* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).\n* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.', 'accessCriteria': 'Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}, 'collaborators': [{'name': 'ADIR, a Servier Group company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}