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

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

Recruiting
18-65 years
All
Phase 1
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Overview

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).

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.

Eligibility

Inclusion Criteria:

  • MYBPC3 mutation
  • Nonobstructive Hypertrophic Cardiomyopathy
  • Left Ventricular Ejection Fraction ≥50%
  • Functioning Implantable Cardiac Defibrillator
  • NYHA Functional Class II or III symptoms
  • NT-proBNP ≥300pg/ml

Exclusion Criteria:

  • High AAV9 neutralizing antibody titer

Study details
    Hypertrophic Cardiomyopathy

NCT05836259

Tenaya Therapeutics

29 May 2024

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