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RECRUITING
NCT07443826
PHASE1/PHASE2

CALM-AF-AI: Counteracting Age-related Loss of Muscle With AAV-Follistatin Combined With Angiogenesis-Inducing VEGF Plasmid Gene Therapy

Sponsor: Unlimited Biotechnology LLC

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03-31

Completion Date

2028-06-30

Last Updated

2026-03-06

Healthy Volunteers

Yes

Interventions

GENETIC

AAV9-Follistatin gene therapy

One-time intramuscular administration of an adeno-associated virus, serotype 9, (AAV9) vector encoding human follistatin.

GENETIC

VEGF Plasmid

Intramuscular supercoiled plasmid DNA gene therapy encoding vascular endothelial growth factor (VEGF).

Locations (1)

GARM

Coxen Hole, Bay Islands, Honduras