Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT05836259 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • GENETIC TN-201

Study Locations (10)

California

  • UC San Diego Altman Clinical and Translational Research Institute - Center for Clinical Research — La Jolla
  • University of California San Francisco — San Francisco

Ohio

  • The Christ Hospital Physicians - The Ohio Heart and Vascular Center — Cincinnati
  • Cleveland Clinic — Cleveland

Georgia

  • Emory University — Atlanta

Massachusetts

  • Brigham and Women's Hospital — Boston

Minnesota

  • Mayo Clinic — Rochester

Oregon

  • Oregon Health & Science University — Portland

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Texas

  • Houston Methodist Hospital — Houston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-08-10
Est. Completion 2032-08
Phase Phase 1

Sponsor

Tenaya Therapeutics

35 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05836259

The ClinicalTrials.gov registry entry for NCT05836259 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tenaya Therapeutics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention — of which TN-201 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05836259 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Ohio, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05836259 about?

NCT05836259 is a clinical study titled "Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM". 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.

What is the current status of trial NCT05836259?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-08-10. Estimated completion is 2032-08.

What conditions does trial NCT05836259 study?

This clinical trial studies the following conditions: Hypertrophic Cardiomyopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05836259?

The interventions under investigation include: TN-201 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05836259?

This trial is sponsored by Tenaya Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05836259 being conducted?

This trial has 10 study locations across California, Georgia, Massachusetts, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial