NCT07216781

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Minicircle · Industry
• Sex: All
• Age: 23 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
GENETIC	Injectable Plasmid Klotho Gene Therapy	Injection of plasmid-delivered Klotho gene therapy

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-10-15
• Last updated: 2026-02-17

Locations

2 sites across 2 countries: United States, Honduras