Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-31 @ 2:19 PM
Study NCT ID:
NCT04258761
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D000077423', 'term': 'Polidocanol'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Multi-center, open label, single ascending dose comparison.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '24 weeks', 'description': 'Incidence (severity and causality) of any local and systemic Adverse Events'}, {'measure': 'Local Skin Reactions (LSR)', 'timeFrame': '24 weeks', 'description': 'At each time point, the number of subjects with presence (and severity) of the following LSRs on a 4 point scale (zero to 3), with a higher score indicating a worse outcome: erythema, edema, tenderness on palpation, bruising, pain, and stinging/burning'}], 'secondaryOutcomes': [{'measure': 'Clinician Submental Fat Scale (CSFS)', 'timeFrame': '24 weeks', 'description': 'Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome'}, {'measure': 'Patient Submental Fat Scale (PSFS)', 'timeFrame': '24 weeks', 'description': 'Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Submental Fat']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.', 'detailedDescription': 'About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a male or non-pregnant female 18-65 years of age\n* Signed informed consent\n* Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline\n* Subject is in good general health\n\nExclusion Criteria:\n\n* Loose skin or prominent platysmal bands in the neck or chin area\n* Recent treatment with anticoagulants\n* Presence of clinically significant health problems'}, 'identificationModule': {'nctId': 'NCT04258761', 'briefTitle': 'A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")', 'organization': {'class': 'INDUSTRY', 'fullName': '10xBio, LLC'}, 'officialTitle': 'A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat', 'orgStudyIdInfo': {'id': '210-9451-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10XB-101 Solution for Injection 1.25%', 'description': 'Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation.', 'interventionNames': ['Drug: 10XB-101 Solution for Injection']}, {'type': 'EXPERIMENTAL', 'label': '10XB-101 Solution for Injection 2.0%', 'description': 'Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.', 'interventionNames': ['Drug: 10XB-101 Solution for Injection']}, {'type': 'EXPERIMENTAL', 'label': '10XB-101 Solution for Injection 3.0%', 'description': 'Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.', 'interventionNames': ['Drug: 10XB-101 Solution for Injection']}, {'type': 'EXPERIMENTAL', 'label': '10XB-101 Solution for Injection 4.5%', 'description': 'Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation.', 'interventionNames': ['Drug: 10XB-101 Solution for Injection']}, {'type': 'EXPERIMENTAL', 'label': '10XB-101 Solution for Injection 6.0%', 'description': 'Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.', 'interventionNames': ['Drug: 10XB-101 Solution for Injection']}], 'interventions': [{'name': '10XB-101 Solution for Injection', 'type': 'DRUG', 'otherNames': ['polidocanol'], 'description': 'Active test article', 'armGroupLabels': ['10XB-101 Solution for Injection 1.25%', '10XB-101 Solution for Injection 2.0%', '10XB-101 Solution for Injection 3.0%', '10XB-101 Solution for Injection 4.5%', '10XB-101 Solution for Injection 6.0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Site 01', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'John Dobak, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': '10xBio, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '10xBio, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}