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Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC

Study acronym: RIDGE-1
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 6, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 7 sitesv13
  2. Site details revised at 1 of 7 sitesv12
  3. Site details revised at 1 of 7 sitesv11
  4. Site details revised at 1 of 7 sitesv10
  5. Study sites: 16 to 7v9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 18 words
    • Study sites revised (16)
    v8
  2. Site details revised at 1 of 16 sitesv7
  3. Study sites: 2 to 16
    • Start date changed from estimate of Apr 1, 2024 to Mar 26, 2024
    • Eligibility criteria expanded, about 2 words
    • Collaborators shortened, about 5 words
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Collaborators expanded, about 5 wordsv3
  7. Study sites: 0 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
Trial Details
NCT Number NCT06228924
Lead Sponsor Tenaya Therapeutics
Conditions
(from sponsor)		 Arrhythmogenic Right Ventricular Cardiomyopathy
Related terms Arrhythmogenic Right Ventricular Dysplasia, Heart Failure
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov