Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT01129661
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2010-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584257', 'term': 'CSL112'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-20', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as measured by the frequency of drug-related clinical adverse events.', 'timeFrame': 'Up to 14 days after infusion of CSL112'}, {'measure': 'Safety and tolerability as measured by liver function tests.', 'timeFrame': 'Up to 14 days after infusion of CSL112'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of lipoprotein.', 'timeFrame': 'Up to 10 days after infusion of CSL112', 'description': 'Plasma levels of lipoprotein.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33217027', 'type': 'DERIVED', 'citation': 'Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '54 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females aged 18 years to less than 55 years\n* Body weigh 45 kg or greater\n\nExclusion Criteria:\n\n* Evidence of a clinically significant medical condition, disorder or disease\n* Evidence of clinically relevant abnormal laboratory test result\n* Evidence of history of alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT01129661', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Limited'}, 'officialTitle': 'An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics, of Intravenous CSL112 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CSLCT-HDL-09-63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline (0.9%)', 'interventionNames': ['Biological: normal saline (0.9%)']}, {'type': 'EXPERIMENTAL', 'label': 'CSL112', 'interventionNames': ['Biological: CSL112 (reconstituted HDL)']}], 'interventions': [{'name': 'CSL112 (reconstituted HDL)', 'type': 'BIOLOGICAL', 'description': 'Single escalating intravenous doses of CSL112', 'armGroupLabels': ['CSL112']}, {'name': 'normal saline (0.9%)', 'type': 'BIOLOGICAL', 'description': 'Single intravenous dose of normal saline (0.9%)', 'armGroupLabels': ['normal saline (0.9%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Russell Basser', 'oldOrganization': 'CSL Limited'}}}}