Health Trials

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

ConditionHypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTenaya Therapeutics

About this trial

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 criteria

Qualifiers

MYBPC3 mutation

Hypertrophic Cardiomyopathy (obstructive and nonobstructive)

Left Ventricular Ejection Fraction ≥45%

NYHA Functional Class II or III symptoms

Disqualifiers

High AAV9 neutralizing antibody titer

Trial design

Treatments tested in this trial

  • TN-201

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tenaya Therapeutics

Lead sponsor

Source ClinicalTrials.gov