Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
Recruiting
Phase 1
Phase 2
Interventional Study
Hypertrophic Cardiomyopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Tenaya Therapeutics · Industry
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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.
Trial Locations
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Eligibility Criteria
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
Contacts