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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.
About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10XB-101 Solution for Injection 1.25% | Experimental | Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
|
| 10XB-101 Solution for Injection 2.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
|
| 10XB-101 Solution for Injection 3.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
|
| 10XB-101 Solution for Injection 4.5% | Experimental | Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
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| 10XB-101 Solution for Injection 6.0% | Experimental | Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10XB-101 Solution for Injection | Drug | Active test article |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence (severity and causality) of any local and systemic Adverse Events | 24 weeks |
| Local Skin Reactions (LSR) | 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Submental Fat Scale (CSFS) | Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome | 24 weeks |
| Patient Submental Fat Scale (PSFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Dobak, MD | 10xBio, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000077423 | Polidocanol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011092 | Polyethylene Glycols |
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Multi-center, open label, single ascending dose comparison.
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|
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Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome
| 24 weeks |
| D005026 |
| Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |