Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT01725594
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2012-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2012-11-06', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of adverse events', 'timeFrame': 'Screening to End of study (up to 4 weeks following randomization)'}], 'secondaryOutcomes': [{'measure': 'AUCinf of CAT-2003', 'timeFrame': 'Days 1, 7 and 14'}, {'measure': 'Cmax of CAT-1004', 'timeFrame': 'Days 1, 7 and14'}, {'measure': 'Changes from baseline for hematology, chemistry, coagulation and urinalysis', 'timeFrame': 'Baseline through End of study (up to 4 weeks)'}, {'measure': 'Changes from baseline for Physical exams', 'timeFrame': 'Baseline through end of study (up to 4 weeks)'}, {'measure': 'Changes from baseline for ECGs', 'timeFrame': 'Baseline through end of study (up to 4 weeks)'}, {'measure': 'Changes from baseline in vital signs', 'timeFrame': 'Baseline through end of study (up to 4 weeks)'}, {'measure': 'Assess the pharmacodynamic effects of multiple doses of CAT-2003 on triglycerides and other lipids (LDL-C, VLDL-C, VLDL-triglycerides, non-HDL-C, total cholesterol, HDL-C), apoB, lipoprotein(a), and PCSK9 in healthy subjects with mild dyslipidemia', 'timeFrame': 'Baseline to end of study (up to 4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Major Inclusion Criteria:\n\n* Provision of written informed consent prior to any study-specific procedure;\n* Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;\n* Satisfies one of the following:\n\n 1. Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (FSH) greater than or equal to 40 IU/L; OR\n 2. Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose;\n\nMajor Exclusion Criteria:\n\n* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations\n* Clinically significant electrocardiogram (ECG) abnormalities or laboratory results as assessed by the investigator, such as QTcF \\>450;\n* Use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer;"}, 'identificationModule': {'nctId': 'NCT01725594', 'briefTitle': 'A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catabasis Pharmaceuticals'}, 'officialTitle': 'A Two-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CAT-2003-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A1, Dose Level 1: CAT 2003 or placebo fasting', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A2, Dose Level 2: CAT 2003 or placebo fasting', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A3, Dose Level 3: CAT 2003 or placebo fasting', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A4, Dose Level 4: CAT 2003 or placebo fasting', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A5, Dose Level 5: CAT 2003 or placebo fasting', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A2: Dose Level 2: CAT 2003 or placebo fed', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A3: Dose level 3:CAT 2003 or placebo fed', 'description': 'Single dose', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B1: Dose level 6: CAT 2003 or placebo', 'description': 'Multiple dose for 14 days', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B2: Dose level 7: CAT 2003 or placebo', 'description': 'Multiple dose for 14 days', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B3: Dose level 8: CAT 2003 or placebo', 'description': 'Multiple dose for 14 days', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B4: Dose level 9: CAT 2003 or placebo', 'description': 'Multiple dose for 14 days', 'interventionNames': ['Drug: CAT 2003', 'Drug: Placebo']}], 'interventions': [{'name': 'CAT 2003', 'type': 'DRUG', 'armGroupLabels': ['Cohort A1, Dose Level 1: CAT 2003 or placebo fasting', 'Cohort A2, Dose Level 2: CAT 2003 or placebo fasting', 'Cohort A2: Dose Level 2: CAT 2003 or placebo fed', 'Cohort A3, Dose Level 3: CAT 2003 or placebo fasting', 'Cohort A3: Dose level 3:CAT 2003 or placebo fed', 'Cohort A4, Dose Level 4: CAT 2003 or placebo fasting', 'Cohort A5, Dose Level 5: CAT 2003 or placebo fasting', 'Cohort B1: Dose level 6: CAT 2003 or placebo', 'Cohort B2: Dose level 7: CAT 2003 or placebo', 'Cohort B3: Dose level 8: CAT 2003 or placebo', 'Cohort B4: Dose level 9: CAT 2003 or placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Cohort A1, Dose Level 1: CAT 2003 or placebo fasting', 'Cohort A2, Dose Level 2: CAT 2003 or placebo fasting', 'Cohort A2: Dose Level 2: CAT 2003 or placebo fed', 'Cohort A3, Dose Level 3: CAT 2003 or placebo fasting', 'Cohort A3: Dose level 3:CAT 2003 or placebo fed', 'Cohort A4, Dose Level 4: CAT 2003 or placebo fasting', 'Cohort A5, Dose Level 5: CAT 2003 or placebo fasting', 'Cohort B1: Dose level 6: CAT 2003 or placebo', 'Cohort B2: Dose level 7: CAT 2003 or placebo', 'Cohort B3: Dose level 8: CAT 2003 or placebo', 'Cohort B4: Dose level 9: CAT 2003 or placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace CPU', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Lukasz Biernat, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medpace, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catabasis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}