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Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM — MyPEAK-1  

Hypertrophic Cardiomyopathy Clinical Trial

Official title:
First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-201, a Recombinant Adenoassociated Virus Serotype 9 (AAV9) Containing Myosin Binding Protein C Transgene, in Adults With MYBPC3 Mutation-Associated Hypertrophic Cardiomyopathy (HCM)

Clinical Trial Summary

This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic MYBPC3 mutation-associated nonobstructive hypertrophic cardiomyopathy (nHCM).

Clinical Trial Description

The study will consist of 2 escalating dose cohorts. The study will enroll at least 6 and as many as 15 patients. All patients will receive active drug. The study will follow patients for 5 years following a single dose of TN-201. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05836259
Study type Interventional
Source Tenaya Therapeutics
Contact Laura Robertson, M.D.
Phone 650-416-1186
Email lrobertson@tenayathera.com
Status Recruiting
Phase Phase 1
Start date August 10, 2023
Completion date December 2029
View Details
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