Klotho Plasmid Gene Therapy for Prevention in Humans

Injectable Plasmid Klotho Gene Therapy

Concentration of Serum α-Klotho Measured by Enzyme-Linked Immunosorbent Assay (pg/mL)

Adverse Events: Number and Percentage of Participants Experiencing Treatment-Emergent Adverse Events as Assessed Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Concentration of Serum Fibroblast Growth Factor 23 (FGF23) Measured by Enzyme-Linked Immunosorbent Assay (pg/mL)

Concentration of Intact Parathyroid Hormone Measured by Two-Site Immunoassay (pg/mL)

Concentration of Serum 1,25-Dihydroxyvitamin D (Calcitriol) Measured by Liquid Chromatography-Tandem Mass Spectrometry (pg/mL)

Concentration of Serum Phosphorus Measured by Clinical Chemistry Analyzer (mg/dL)

Urinary Phosphate Excretion Measured by Clinical Chemistry Assay (mg/24 h or mg/g Creatinine)

Concentration of Serum Cystatin C Measured by Immunoassay (mg/L)

Change From Baseline in World Health Organization Quality of Life Brief Version Domain Scores (0-100)

Change From Baseline in Flanker Inhibitory Control and Attention Test T-Score (Mean 50 ± 10)

Change From Baseline in Dimensional Change Card Sort Test T-Score (Mean 50 ± 10)

Change From Baseline in Pattern Comparison Processing Speed Test T-Score (Mean 50 ± 10)

Change From Baseline in Picture Sequence Memory Test T-Score, Forms A and B (Mean 50 ± 10)

Concentration of Total Serum Bilirubin Measured by Diazo Method (mg/dL)

Change From Baseline in Picture Vocabulary Test T-Score (Mean 50 ± 10)

Change From Baseline in Reynolds Intellectual Assessment Scales-Second Edition (RIAS-2) Composite Scores (Standard Score Mean 100 ± 15)

Concentration of Serum Glucose Measured by Clinical Chemistry Analyzer (mg/dL)

Concentration of Total Serum Calcium Measured by Clinical Chemistry Analyzer (mg/dL)

Concentration of Ionized Calcium Measured by Ion-Selective Electrode (mmol/L)

Concentration of Serum Sodium Measured by Ion-Selective Electrode (mmol/L)

Concentration of Serum Potassium Measured by Ion-Selective Electrode (mmol/L)

Concentration of Serum Chloride Measured by Ion-Selective Electrode (mmol/L)

Concentration of Serum Bicarbonate (CO₂) Measured by Clinical Chemistry Analyzer (mmol/L)

Concentration of Blood Urea Nitrogen (BUN) Measured by Clinical Chemistry Analyzer (mg/dL)

Concentration of Serum Creatinine Measured by Clinical Chemistry Analyzer (mg/dL)

Concentration of Serum Albumin Measured by Clinical Chemistry Analyzer (g/dL)

Concentration of Total Serum Protein Measured by Biuret Method (g/dL)

Concentration of Alkaline Phosphatase (ALP) Measured by Clinical Chemistry Analyzer (IU/L)

Concentration of Alanine Aminotransferase (ALT) Measured by Clinical Chemistry Analyzer (IU/L)

Concentration of Aspartate Aminotransferase (AST) Measured by Clinical Chemistry Analyzer (IU/L)

Concentration of High-Sensitivity C-Reactive Protein (hs-CRP) Measured by Immunoturbidimetric Assay (mg/L)

Concentration of Asymmetric Dimethylarginine (ADMA) Measured by Liquid Chromatography-Tandem Mass Spectrometry (µmol/L)

Concentration of Platelet Factor 4 (PF4) Measured by Enzyme-Linked Immunosorbent Assay (ng/mL or OD Units)

Epigenetic Biological Age Estimated From Whole-Genome DNA Methylation Profiles (years)

Estimated Brain Age: Derived From Kernel Flow Functional Near-Infrared Spectroscopy (fNIRS) Analysis (years)

Cognitive Performance Index and Domain Percentiles Derived From Kernel Flow functional near-infrared spectroscopy (fNIRS) and Behavioral Metrics (percentile where higher = better)