A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin (Double Chin)

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Open Label, Single Ascending Dose Safety and Tolerability Study of Subcutaneously Administered 10XB-101 in Adult Subjects With Excessive Submental Fat

Conditions
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Submental Fat

Intervention / Treatment
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* Drug: 10XB-101 Solution for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or non-pregnant female 18-65 years of age Signed informed consent Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline Subject is in good general health Exclusion Criteria: Loose skin or prominent platysmal bands in the neck or chin area Recent treatment with anticoagulants Presence of clinically significant health problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multi-center, open label, single ascending dose comparison.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10XB-101 Solution for Injection 1.25%<br>Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation. | Drug: 10XB-101 Solution for Injection<br>* Active test article<br>|
| Experimental: 10XB-101 Solution for Injection 2.0%<br>Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. | Drug: 10XB-101 Solution for Injection<br>* Active test article<br>|
| Experimental: 10XB-101 Solution for Injection 3.0%<br>Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. | Drug: 10XB-101 Solution for Injection<br>* Active test article<br>|
| Experimental: 10XB-101 Solution for Injection 4.5%<br>Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation. | Drug: 10XB-101 Solution for Injection<br>* Active test article<br>|
| Experimental: 10XB-101 Solution for Injection 6.0%<br>Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation. | Drug: 10XB-101 Solution for Injection<br>* Active test article<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome | 24 weeks |