RecruitingPhase 1/2

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

United States30 participantsStarted 2023-08-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number and severity of Adverse Events over the course of the study.

Timeframe: 5 Years

Number of Serious Adverse Events related to study drug.

Timeframe: 5 Years

Trial details

NCT IDNCT05836259

SponsorTenaya Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Matt Pollman, M.D.

650-209-8092 mpollman@tenayathera.com

View on ClinicalTrials.gov More Hypertrophic Cardiomyopathy trials