RecruitingPhase 1Phase 2NCT07443826

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

Sponsor

Unlimited Biotechnology LLC

Enrollment

12 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Age-related Muscle Decline

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.

Eligibility

Min Age: 35 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AAV9-Follistatin gene therapy and VEGF Plasmid for people with age-related muscle decline. The study is currently recruiting participants at 1 location. People eligible for this study include aged 45 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAAV9-Follistatin gene therapy

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

GENETICVEGF Plasmid

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

Locations(1)

GARM

Coxen Hole, Bay Islands, Honduras

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NCT07443826