Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 4:30 AM
Study NCT ID:
NCT01443650
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)', 'timeFrame': '15 days'}, {'measure': 'Erythema at injection site by measuring diameter and qualitative assessment', 'timeFrame': '15 days'}, {'measure': 'Edema at injection site by measuring diameter and qualitative assessment', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter - time to maximum concentration (tmax)', 'timeFrame': 'Up to 85 days'}, {'measure': 'Pharmacodynamics: Change in LDL-C from baseline', 'timeFrame': 'Up to 85 days'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to 85 days'}, {'measure': 'Assessment of PK parameter - maximum concentration (Cmax)', 'timeFrame': 'Up to 85 days'}, {'measure': 'Assessment of PK parameter - area under curve (AUC)', 'timeFrame': 'Up to 85 days'}, {'measure': 'Assessment of PK parameter - area under curve versus time curve (AUC0-D29)', 'timeFrame': 'Zero to Day 29'}, {'measure': 'Assessment of PK parameter - plasma concentration on Day 29 (C D29)', 'timeFrame': 'Day 29'}, {'measure': 'Assessment of PK parameter - terminal elimination half-life (t1/2z)', 'timeFrame': 'Up to 85 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nInjection Site Tolerability\n\nSecondary Objectives:\n\n* To assess the safety profile of alirocumab SAR236553 (REGN727)\n* To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)', 'detailedDescription': 'Total duration for each subject (not including screening) will be approximately 85 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Serum LDL-C levels \\>100 mg/dL.\n\nExclusion criteria:\n\n* Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.\n* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. Subjects must be willing to maintain a consistent diet for the duration of the study.\n* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.\n* Fasting serum triglycerides \\>200 mg/dL measured after an 8-12 hour fast.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01443650', 'briefTitle': 'Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PKD12275'}, 'secondaryIdInfos': [{'id': 'U1111-1120-0670', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) (Formulation A x 1)', 'description': 'A single subcutaneous injection of Formulation A', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}, {'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) (Formulation B x 1)', 'description': 'A single subcutaneous injection of Formulation B', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}, {'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) (Formulation A x 2)', 'description': '2 single subcutaneous injections of Formulation A', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}], 'interventions': [{'name': 'alirocumab SAR236553 (REGN727)', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: subcutaneous', 'armGroupLabels': ['alirocumab SAR236553 (REGN727) (Formulation A x 1)', 'alirocumab SAR236553 (REGN727) (Formulation A x 2)', 'alirocumab SAR236553 (REGN727) (Formulation B x 1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}