Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans
Start Date
10/6/2025
Completion Date
8/1/2026
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.
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 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.
Eligibility Criteria
Age Range: 23 years to 90 years
Interventions
Injectable Plasmid Klotho Gene Therapy
Conditions
Locations
Apeiron Center
Austin, Texas 78701
United States
GARM Clinic
Roatán, Bay Islands
Honduras