RecruitingPhase 1NCT07216781

Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans

Evaluating the Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans: An Interventional, Non-Placebo-Controlled Pilot Phase Study

Sponsor

Minicircle

Enrollment

24 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Adults

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

Min Age: 23 YearsMax Age: 90 Years

Inclusion Criteria4

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 Criteria5

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

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Interventions

GENETICInjectable Plasmid Klotho Gene Therapy

Injection of plasmid-delivered Klotho gene therapy

Locations(2)

Apeiron Center

Austin, Texas, United States

GARM Clinic

Roatán, Bay Islands, Honduras

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NCT07216781

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