Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans

Last updated: August 26, 2026
Sponsor: Minicircle
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

Injectable Plasmid Klotho Gene Therapy

Clinical Study ID

NCT07216781
MINICIRCLE-KLO
  • Ages 23-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to investigate the safety and efficacy of a gene therapy for Klotho, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of the Klotho gene therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is open to morphological change

  • If female, participant agrees to maintain contraception

  • If female, participant agrees to take a pregnancy test

  • If female, participant agrees to a pregnancy waiver

Exclusion

Exclusion Criteria:

  • Women of childbearing potential who are unwilling or unable to use effectivecontraception for the duration of the study

  • History of cancer diagnosis

  • Preexisting medical issues that may be exacerbated by the treatment

  • Has received any gene therapy within the past 12 months

  • Unwilling or unable to provide written informed consent

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: Injectable Plasmid Klotho Gene Therapy
Phase: 1
Study Start date:
October 06, 2025
Estimated Completion Date:
August 31, 2026

Study Description

Note that the investigational product will be administered at a site outside of the U.S. which is not under FDA jurisdiction, and only non-treatment pre/post outcome assessments (e.g., cognitive assessments or blood sample collection) occur at the U.S. site.

Participants will take part in cognitive and health testing before and after administration of plasmid-delivered Klotho gene therapy. The method of administration will be subcutaneous injection into abdominal fat deposits. Klotho may improve cognitive function, kidney function, healthspan, and lifespan. Healthy volunteers will partake in a series of blood draws, health screenings, questionnaires, brain perfusion/function measures, and cognitive testing multiple times before and after the intervention.

Connect with a study center

  • GARM Clinic

    Roatán, Bay Islands
    Honduras

    Site Not Available

  • Apeiron Center

    Austin, Texas 78701
    United States

    Site Not Available

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