Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 8:04 PM
Study NCT ID:
NCT05881993
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacodynamics', 'timeFrame': '30 days', 'description': 'Concentraion of sFLt-1'}], 'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '30 days', 'description': 'Number of participants with treatment-related adverse events'}, {'measure': 'Pain at Site of Injection', 'timeFrame': '30 days', 'description': 'Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening)'}, {'measure': 'Tenderness at Site of Injection', 'timeFrame': '30 Days', 'description': 'Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening)'}, {'measure': 'Erythema at Site of Injection', 'timeFrame': '30 days', 'description': 'Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening)'}, {'measure': 'Swelling at Site of Injection', 'timeFrame': '30 Days', 'description': 'Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening)'}], 'secondaryOutcomes': [{'measure': 'Cmax of CBP-4888', 'timeFrame': '30 days', 'description': 'Peak Plasma Concentration'}, {'measure': 'AUC of CBP-4888', 'timeFrame': '30 days', 'description': 'Area Under the Plasma Concentration Versus Time Curve'}, {'measure': 'Tmax of CBP-4888', 'timeFrame': '30 days', 'description': 'Time to maximum plasma concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.', 'detailedDescription': 'This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-pregnant female subjects\n* Body mass index (BMI) ≥ 18.5 and ≤ 35.0 kg/m2\n* Medically healthy, defined as having no clinically significant abnormal screening results including clinical laboratory evaluations, medical history, vital signs, ECG, and physical examination as deemed by the Investigator.\n\nExclusion Criteria:\n\n* Screening blood pressure \\< 100/60 mmHg or \\> 140/90 mmHg\n* Screening heart rate that is \\< 40 bpm or \\> 99 bpm\n* Clinically significant ECG abnormality at screening\n* Used prescription medication within 14 days prior to dosing\n* Used over the counter (OTC) medications (including herbal products, nutritional supplements, dietary supplements, and/or vitamins) within 7 days prior to dosing\n* Donated blood or had significant blood loss within 56 days prior to dosing'}, 'identificationModule': {'nctId': 'NCT05881993', 'briefTitle': 'Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Comanche Biopharma'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-4888 in Healthy, Non-Pregnant Female Subjects', 'orgStudyIdInfo': {'id': 'CBP-4888-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBP-4888', 'description': 'CBP-4888 administered once as a subcutaneous dose.', 'interventionNames': ['Drug: CBP-4888']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal Saline administered once as a subcutaneous dose.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CBP-4888', 'type': 'DRUG', 'description': 'siRNA therapeutic', 'armGroupLabels': ['CBP-4888']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Normal Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Comanche Biopharma Clinical Research Site #1', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Allison August, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comanche Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}