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

Sponsor
10xBio, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04258761
Collaborator
(none)
15
Enrollment
1
Location
5
Arms
34.7
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 10XB-101 Solution for Injection
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Multi-center, open label, single ascending dose comparison.Multi-center, open label, single ascending dose comparison.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 10, 2019
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10XB-101 Solution for Injection 1.25%

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

Drug: 10XB-101 Solution for Injection
Active test article
Experimental: 10XB-101 Solution for Injection 2.0%

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

Drug: 10XB-101 Solution for Injection
Active test article
Experimental: 10XB-101 Solution for Injection 3.0%

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

Drug: 10XB-101 Solution for Injection
Active test article
Experimental: 10XB-101 Solution for Injection 4.5%

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

Drug: 10XB-101 Solution for Injection
Active test article
Experimental: 10XB-101 Solution for Injection 6.0%

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

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

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [24 weeks]

    Incidence (severity and causality) of any local and systemic Adverse Events

  2. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 01 San Diego California United States 92123

Sponsors and Collaborators

  • 10xBio, LLC

Investigators

  • Study Director: John Dobak, MD, 10xBio, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
10xBio, LLC
ClinicalTrials.gov Identifier:
NCT04258761
Other Study ID Numbers:
  • 210-9451-202
First Posted:
Feb 6, 2020
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 29, 2021