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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Submental Fat
• Intervention / Treatment: Drug: 10XB-101 Solution for Injection; Drug: 10XB-101 Vehicle Solution for Injection

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Site 03
    • San Diego, California, United States, 92123
      • Site 01
    • San Diego, California, United States, 92122
      • Site 02
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Site 04

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10XB-101 Solution for Injection, 2.0%; 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; One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
Experimental: 10XB-101 Solution for Injection, 3.0%; 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; One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
Experimental: 10XB-101 Solution for Injection, 4.5%; 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; One of the three concentrations of 10XB-101 will be evaluated against placebo for submental fat reduction.
Placebo Comparator: 10XB-101 Vehicle Solution for Injection; 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; This is the placebo control

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

Collaborators and Investigators

• Sponsor: 10xBio, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 210-9451-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No