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

Phase 2

Completed

• Conditions: Submental Fat
• Interventions: Drug: 10XB-101 Solution for Injection

• Registration Number: NCT04258761
• Lead Sponsor: 10xBio, LLC

Brief Summary

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.

Detailed Description

About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
10XB-101 Solution for Injection 1.25%	10XB-101 Solution for Injection	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 4.5%	10XB-101 Solution for Injection	Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
10XB-101 Solution for Injection 3.0%	10XB-101 Solution for Injection	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 6.0%	10XB-101 Solution for Injection	Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.
10XB-101 Solution for Injection 2.0%	10XB-101 Solution for Injection	Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Primary Outcome Measures

Name	Time	Method
Adverse Events	24 weeks	Incidence (severity and causality) of any local and systemic Adverse Events
Local Skin Reactions (LSR)	24 weeks	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

Secondary Outcome Measures

Name	Time	Method
Clinician Submental Fat Scale (CSFS)	24 weeks	Change from Baseline in the CSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome
Patient Submental Fat Scale (PSFS)	24 weeks	Change from Baseline in the PSFS on a five-point scale (zero to 4), with a higher score indicating a worse outcome

Trial Locations

Locations (1)

Site 01; 🇺🇸 San Diego, California, United States