Status: Recruiting
CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy
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.
Participants needed: 12
Trial details
Phase: Phase 1, Phase 2Age: 35-75Biological sex: AllType: InterventionalSponsor: Unlimited Biotechnology LLCUpdated: Jul 13, 2026Locations: 1
Eligibility criteria
Voluntary written informed consent obtained prior to any study-related procedure... [+10]
Pregnancy, breastfeeding, or intent to become pregnant; premenopausal status (un... [+72]