Status:

RECRUITING

Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans

Lead Sponsor:

Minicircle

Conditions:

Healthy Adults

Eligibility:

All Genders

23-90 years

Phase:

PHASE1

Brief 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 unders...

Detailed 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 asses...

Eligibility Criteria

Inclusion

  • 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

  • Women of childbearing potential who are unwilling or unable to use effective contraception 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

Key Trial Info

Start Date :

October 6 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT07216781

Start Date

October 6 2025

End Date

August 1 2026

Last Update

October 15 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Apeiron Center

Austin, Texas, United States, 78701

2

GARM Clinic

Roatán, Bay Islands, Honduras