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NCT04258761 Clinical Trial

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

Submental Fat Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04258761
Other study ID # 210-9451-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 10, 2019
Est. completion date August 31, 2022

Study information
Verified date April 2024
Source 10xBio, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date August 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 10XB-101 Solution for Injection
Active test article

Locations
Country Name City State
United States Site 01 San Diego California

Sponsors (1)
Lead Sponsor Collaborator
10xBio, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Incidence (severity and causality) of any local and systemic Adverse Events 24 weeks
Primary 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 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
Secondary 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
See also
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Active, not recruiting NCT05154955 - A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat Phase 2
Completed NCT05763160 - An Open-label Study That Will Test a Second Treatment Session of RZL-012. Phase 2
Completed NCT03946592 - Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat Phase 3
Completed NCT04867434 - Efficacy and Safety of RZL-012 on Submental Fat Reduction Phase 2
Completed NCT05466448 - An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects. Phase 1/Phase 2
Completed NCT04086823 - A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers. Phase 2
Completed NCT02159729 - Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 Phase 2
Completed NCT05195112 - Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat Phase 3
Completed NCT03005717 - Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat Phase 2
Completed NCT02163902 - Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 Phase 3
Completed NCT05476094 - Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects Phase 1