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

  • STATUS
    Recruiting
  • participants needed
    6
  • sponsor
    10xBio, LLC
Updated on 19 February 2024

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.

Details
Condition Submental Fat
Age 18years - 65years
Treatment 10XB-101 Solution for Injection
Clinical Study IdentifierNCT04258761
Sponsor10xBio, LLC
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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