A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).

Official Title
-----------------
A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat

Conditions
-----------------
Submental Fat

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or non-pregnant female 18 to 65 years old. Subject has provided written informed consent. Subject has qualifying Submental Fat evaluation score. Subject has had a stable body weight for the past 6 months prior to starting study. Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject has loose skin in the submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator. Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery). Subject has any medical condition that affects clotting and/or platelet function Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. | Drug: 10XB-101 Solution for Injection<br>* One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.<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. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. | Drug: 10XB-101 Solution for Injection<br>* One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.<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. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. | Drug: 10XB-101 Solution for Injection<br>* One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.<br>|
| Placebo Comparator: 10XB-101 Vehicle Solution for Injection<br>Participants receive 10XB-101 Vehicle Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4-6 weeks for up to 6 treatments. | Drug: 10XB-101 Vehicle Solution for Injection<br>* This is the placebo control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Submental Fat Scale (CSFS) | Change from Baseline after final treatment. CSFS is a 5 point scale, with a higher score indicating higher severity | 24 weeks after final injection treatment | 
| Patient Submental Fat Scale (PSFS) | Change from Baseline after final treatment. PSFS is a 5 point scale, with a higher score indicating higher severity | 24 weeks after final injection treatment |