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

10xBio

Status and phase: Completed; Phase 2

Conditions: Submental Fat

Treatments: Drug: 10XB-101 Solution for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04258761

210-9451-202

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

10XB-101 Solution for Injection 1.25%

Experimental group

Description:

Participants receive 10XB-101 Solution for Injection, 1.25% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection 2.0%

Experimental group

Description:

Participants receive 10XB-101 Solution for Injection, 2.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection 3.0%

Experimental group

Description:

Participants receive 10XB-101 Solution for Injection, 3.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection 4.5%

Experimental group

Description:

Participants receive 10XB-101 Solution for Injection, 4.5% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Treatment:

Drug: 10XB-101 Solution for Injection

10XB-101 Solution for Injection 6.0%

Experimental group

Description:

Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL on Day 1 of subject participation.

Treatment:

Drug: 10XB-101 Solution for Injection