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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: Recruiting Phase 1 study of Hypertrophic Cardiomyopathy, sponsored by Tenaya Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2032-08 |
| Phase | Phase 1 |
What NCT05836259 shows while recruiting
NCT05836259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,348-participant average among 10 other Hypertrophic Cardiomyopathy trials with a reported enrollment target (98% lower).
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 lists 10 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Hypertrophic Cardiomyopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05836259's enrollment target sits among peer trials
30 10th of 10 higher than 1 of 10 other Hypertrophic Cardiomyopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertrophic Cardiomyopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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