NCT04258761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

January 27, 2020

Last Update Submit

April 8, 2024

Conditions

Submental Fat

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

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

    24 weeks

  • 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 Outcomes (2)

  • Clinician Submental Fat Scale (CSFS)

    24 weeks

  • Patient Submental Fat Scale (PSFS)

    24 weeks

Study Arms (5)

10XB-101 Solution for Injection 1.25%

EXPERIMENTAL

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

10XB-101 Solution for Injection 2.0%

EXPERIMENTAL

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

10XB-101 Solution for Injection 3.0%

EXPERIMENTAL

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

10XB-101 Solution for Injection 4.5%

EXPERIMENTAL

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

10XB-101 Solution for Injection 6.0%

EXPERIMENTAL

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

Interventions

10XB-101 Solution for InjectionDRUG

Active test article

Also known as: polidocanol
10XB-101 Solution for Injection 1.25%10XB-101 Solution for Injection 2.0%10XB-101 Solution for Injection 3.0%10XB-101 Solution for Injection 4.5%10XB-101 Solution for Injection 6.0%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Loose skin or prominent platysmal bands in the neck or chin area
  • Recent treatment with anticoagulants
  • Presence of clinically significant health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 01

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

InjectionsPolidocanol

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsPolyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • John Dobak, MD

    10xBio, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Multi-center, open label, single ascending dose comparison.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 6, 2020

Study Start

October 10, 2019

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)