Safety and Efficacy of Klotho and Follistatin Gene Therapy

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.

• Change From Baseline in World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Domain Scores (0-100) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (5 timepoints)]
• Change From Baseline in Pattern Comparison Processing Speed Test T-Score (Mean 50 ± 10) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change From Baseline in Picture Sequence Memory Test T-Score, Forms A and B (Mean 50 ± 10) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change From Baseline in Flanker Inhibitory Control and Attention Test T-Score (Mean 50 ± 10) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change From Baseline in Dimensional Change Card Sort Test T-Score (Mean 50 ± 10) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change From Baseline in Picture Vocabulary Test T-Score (Mean 50 ± 10) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (5 timepoints)]
• Epigenetic Biological Age Estimated From Whole-Genome Deoxyribonucleic Acid (DNA) Methylation Profiles (change from baseline) (years) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (5 timepoints)]
• Timed one leg stance change from baseline (seconds) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change from baseline in number of squats performed (count) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change from baseline in number of push-ups performed (count) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Number of sit-ups performed (change from baseline) (count) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (4 timepoints)]
• Change from Baseline: Concentration of High-Sensitivity C-Reactive Protein (hs-CRP) Measured by Immunoturbidimetric Assay (mg/L) [Срок оценки: From 1 month prior to treatment to 3 months after treatment (5 timepoints)]