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First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults with PKP2 Mutation-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

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Trial Profile

First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults with PKP2 Mutation-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs TN-401 (Primary)
  • Indications Arrhythmogenic right ventricular dysplasia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms RIDGE-1
  • Sponsors Tenaya Therapeutics

Most Recent Events

  • 10 Mar 2025 According to a Tenaya Therapeutics media release, the company expects to complete enrollment of Cohort 1 of the RIDGE-1 Phase 1b clinical trial in the first half of 2025.
  • 03 Feb 2025 According to a Tenaya Therapeutics media release, the company received $8. 0 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM),Proceeds from the grant will help fund Phase 1b RIDGE-1 clinical trial of TN-401 gene therapy.Initial Data from RIDGE-1 Phase 1b Clinical Trial Expected in 2H25.
  • 13 Jan 2025 According to a Tenaya Therapeutics media release, the company expects to complete enrollment of Cohort 1 of the RIDGE-1 Phase 1b clinical trial in the first half of 2025. Initial clinical data from the first cohort of patients receiving TN-401 at the 3E13 vg/kg dose, including safety and post-dose biopsy results, is expected in the second half of 2025. first ex-U.S. clinical site in the first half of 2025.

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