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Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

RECRUITINGPhase 1/2Sponsored by Tenaya Therapeutics
Actively Recruiting
PhasePhase 1/2
SponsorTenaya Therapeutics
Started2023-08-10
Est. completion2027-08
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →

NCT05836259

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 hypertrophic cardiomyopathy (HCM) caused by mutations in the MYBPC3 gene.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* MYBPC3 mutation
* Hypertrophic Cardiomyopathy (obstructive and nonobstructive)
* Left Ventricular Ejection Fraction ≥45%
* NYHA Functional Class II or III symptoms
* NT-proBNP ≥160pg/ml

Exclusion Criteria:

* High AAV9 neutralizing antibody titer

Conditions2

Heart DiseaseHypertrophic Cardiomyopathy

Locations10 sites

UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research
La Jolla, California, 92093
Matt Fahey858-534-3798mjfahey@health.ucsd.edu
University of California San Francisco
San Francisco, California, 94117
Emma Reagan415-514-7280Emma.reagan@ucsf.edu
Emory University
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Mayo Clinic
Rochester, Minnesota, 55905
Sierra Slade507-422-5433Slade.Sierra@mayo.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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