Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT06005402
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of CSX-1004
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083682', 'term': 'Opiate Overdose'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single ascending dose study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '4 months', 'description': 'Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies'}], 'primaryOutcomes': [{'measure': 'Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation', 'timeFrame': '5 months', 'description': 'Incidence, intensity, and causality of adverse events'}, {'measure': 'Clinical laboratory assessments', 'timeFrame': '5 months', 'description': 'Hematology, biochemistry, and urinalysis'}, {'measure': 'Vital signs', 'timeFrame': '5 months', 'description': 'Blood pressure and pulse rate'}, {'measure': '12-Lead electrocardiogram', 'timeFrame': '5 months', 'description': 'Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals'}, {'measure': 'Physical examination', 'timeFrame': '5 months', 'description': "Complete physical examination, assessing the subject's overall health and physical condition"}, {'measure': 'Infusion site examination', 'timeFrame': '6 days', 'description': 'Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '4 months', 'description': 'Maximum serum concentration'}, {'measure': 'AUCinf', 'timeFrame': '4 months', 'description': 'Area under the curve from time zero extrapolated to infinity'}, {'measure': 'AUClast', 'timeFrame': '4 months', 'description': 'Area under the curve from time zero to the last measurable concentration'}, {'measure': 'Tmax', 'timeFrame': '4 months', 'description': 'Time to maximum serum concentration'}, {'measure': 't1/2', 'timeFrame': '4 months', 'description': 'beta terminal elimination half-life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Overdose', 'Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up.\n\nThe primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects.\n\nThe secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Healthy male or female subjects, aged 18 to 50 years, inclusive,\n* Minimum weight of 50.0 kg and maximum weight of 100.0 kg\n* Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive\n\nMajor Exclusion Criteria:\n\n* Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase\n* Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted.\n* History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.'}, 'identificationModule': {'nctId': 'NCT06005402', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of CSX-1004', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cessation Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults', 'orgStudyIdInfo': {'id': 'CSX-1004.101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSX-1004', 'description': 'Single doses of CSX-1004 Injection', 'interventionNames': ['Biological: CSX-1004']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sterile saline for injection', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'CSX-1004', 'type': 'BIOLOGICAL', 'description': 'Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs', 'armGroupLabels': ['CSX-1004']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Sterile saline for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Dr. Vince Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Steven Hull, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Vince Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cessation Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dr. Vince Clinical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}