This Phase 1/2a, open-label, non-randomized study is designed to evaluate the safety and tolerability of intramuscular AAV9-Follistatin gene therapy administered either as monotherapy or in combination with a VEGF-encoding plasmid. Secondary objectives include the assessment of preliminary signals of biological and functional activity, including changes in skeletal muscle mass and performance.
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Number of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs)
Timeframe: Day 1 through Day 90 after AAV administration
Number of participants with dose-limiting toxicities (DLTs)
Timeframe: Day 1 through Day 21 after AAV administration