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NCT05836259 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Hypertrophic Cardiomyopathy, sponsored by Tenaya Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
10
Study locations

NCT05836259 is a Phase 1 study of Hypertrophic Cardiomyopathy that is actively recruiting participants, run by Tenaya Therapeutics. The registered enrollment target is 30 participants, below the 1,348-participant average among 10 other Hypertrophic Cardiomyopathy trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT05836259, a Phase 1 study of Hypertrophic Cardiomyopathy, is actively recruiting participants, sponsored by Tenaya Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
10
Study locations

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.

Conditions Studied

Hypertrophic Cardiomyopathy

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

4 total trials

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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, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,348-participant average among 10 other Hypertrophic Cardiomyopathy trials with a reported enrollment target (98% lower). The listed sponsor is Tenaya Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT05836259 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Ohio, Georgia.

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.

What interventions are being tested in trial NCT05836259?

The interventions under investigation include: TN-201 (GENETIC).

Who is sponsoring clinical trial NCT05836259?

This trial is sponsored by Tenaya Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.