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RecruitingPhase 1/Phase 2

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

Tenaya Therapeutics · NCT05836259

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
30
US sites recruiting
5
Study start
August 10, 2023
Record last updated
March 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TN-201

Conditions: Hypertrophic Cardiomyopathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research

    La Jolla, CA 92093

    Site contact: Matt Fahey · 858-534-3798 · mjfahey@health.ucsd.edu

  • University of California San Francisco

    San Francisco, CA 94117

    Site contact: Emma Reagan · 415-514-7280 · Emma.reagan@ucsf.edu

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Sierra Slade · 507-422-5433 · Slade.Sierra@mayo.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Rachael Landis · 216-444-3650 · LANDISR@ccf.org

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Jennifer Garrett · 281-222-9983 · jmgarrett@houstonmethodist.org

Study contacts (from the official record)

  • Matt Pollman, M.D. · 650-209-8092 · mpollman@tenayathera.com
  • LaTanya Tomlinson, RN, MHSA · 650-825-6990 · clinical.trials@tenayathera.com
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Multi-center, Open-label, Single-ascending Dose Study of Safety… (NCT05836259) | Bored Studies