NCT07285629

Safety and Efficacy of Klotho and Follistatin Gene Therapy

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Minicircle · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Healthy participants will take part in cognitive and health testing before and after administration of plasmid-delivered nonviral klotho and follistatin gene therapy. The method of administration will be subcutaneous injection into abdominal fat deposits. Klotho and follistatin plasmid gene therapy have the potential to improve physical function, cognitive function, kidney function, body composition, epigenetic age, and subjective well being. 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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
GENETIC	Follistatin and klotho gene therapy	Injection of nonviral plasmid-delivered follistatin and klotho gene therapy

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-12-16
• Last updated: 2026-01-08

Locations

2 sites across 2 countries: United States, Honduras