Study to Evaluate Safety and Effects of Injectable Klotho Gene Therapy in Healthy Adults Aged 23 to 90

What this Trial Is About

Researchers are investigating the safety and effects of a gene therapy that delivers the Klotho gene using a nonviral plasmid in healthy adults aged 23 to 90 years. This early phase study aims to better understand how this gene therapy may impact cognitive abilities and overall health, including kidney function and lifespan. The study is sponsored by Minicircle and includes detailed monitoring of biological and cognitive changes over time. Participants will receive the Klotho gene therapy through a subcutaneous injection into abdominal fat. The study does not involve a placebo group and is conducted partly outside the U.S. for the treatment administration, while pre- and post-treatment assessments occur at a U.S. site. Throughout the study, participants will undergo multiple blood draws, cognitive tests, brain function measurements, and health screenings at scheduled intervals before and after receiving the gene therapy. During the trial, participants will be evaluated with various blood tests to measure serum markers and hormones related to kidney and metabolic function. Cognitive tests and brain imaging assessments will also be conducted repeatedly to assess changes in cognitive performance and brain age. Safety is closely monitored by tracking adverse events reported by participants. The study includes visits extending up to six months after treatment, with detailed follow-up to understand the therapys impact on quality of life and health markers.

Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans