Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-27 @ 12:07 AM
Study NCT ID:
NCT00927459
Status:
TERMINATED
Last Update Posted:
2010-01-22
First Post:
2009-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Potential for immune stimulation to interfere with further dose escalation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-21', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of PRO-040201', 'timeFrame': '29 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of PRO-040201 in Humans', 'timeFrame': '48 hours'}, {'measure': 'Pharmacodynamics of PRO-040201 in Humans', 'timeFrame': '29 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cholesterol', 'coronary artery disease'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting, stable LDL-C ≥ 160 mg/dL\n* Fasting, stable triglyceride \\< 400 mg/dL\n* BMI between 22 and 35 kg/m2, inclusive\n* Females must be of non-child bearing potential\n* Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion\n\nExclusion Criteria:\n\n* Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease\n* Cancer within 5 years prior to screening\n* History of congestive heart failure or chronic heart failure\n* Uncontrolled cardiac arrhythmias\n* History of coronary heart disease\n* Clinically significant abnormal baseline ECG\n* History of additional risk factors for torsades de pointes\n* Hepatitis B, C, or HIV positive\n* Current diagnosis or known history of liver disease\n* A marked baseline prolongation of QT/QTc interval\n* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) \\>3 x upper limit of normal (ULN) at screening\n* Alanine aminotransferase, AST, GGT, or total bilirubin \\>2 x ULN at screening\n* Serum creatinine \\> 1.5 mg/dL\n* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening\n* Concomitant use of medications that prolongs the QT/QTc interval\n* Treatment with lipid lowering therapy within 30 days prior to screening\n* Use of investigational drug within 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT00927459', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arbutus Biopharma Corporation'}, 'officialTitle': 'A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'TKM-ApoB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO-040201', 'description': 'PRO-040201 with placebo control in each cohort', 'interventionNames': ['Drug: PRO-040201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PRO-040201 with placebo control in each cohort', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PRO-040201', 'type': 'DRUG', 'description': 'Single dose IV infusion', 'armGroupLabels': ['PRO-040201']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Douglas Logan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medpace Clinical Pharmacology Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbutus Biopharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Murray, PhD, CEO', 'oldOrganization': 'Tekmira Pharmaceuticals Corporation'}}}}