Study of Safety and Effects of Injectable Klotho and Follistatin Gene Therapy in Healthy Adults Aged 50 to 80

What this Trial Is About

This research aims to investigate the safety and effects of a combination gene therapy using klotho and follistatin in healthy adults aged 50 to 80 years. The study evaluates how this nonviral plasmid gene therapy may impact cognitive and physical health, including potential improvements in physical function, kidney function, body composition, and subjective well-being. It is an early-phase interventional trial conducted by the sponsor Minicircle. Participants will receive the gene therapy through a subcutaneous injection into abdominal fat. The treatment is administered at a site outside the U.S., while pre- and post-treatment assessments, including cognitive and health testing, occur within the U.S. The study involves monitoring changes in various biological markers and health measures over several months following treatment. During the study, participants will undergo evaluations such as blood tests, cognitive assessments, and physical performance tests before treatment and at multiple follow-up visits up to three months after therapy. Researchers will measure serum levels of klotho and follistatin, track any treatment-related adverse events, and assess changes in quality of life, cognitive test scores, biological age markers, physical function, and various laboratory parameters. This comprehensive monitoring aims to gather detailed information about the therapys safety and potential health benefits.

Safety and Efficacy of Klotho and Follistatin Gene Therapy