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

Study acronym: MyPEAK-1
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 2 of 10 sitesv16
  2. Site contacts updated at 1 of 10 sitesv15
  3. Site details revised at 5 of 10 sitesv14
  4. Phase: Phase 1 to Phase 1/2v13 Show 7 more changesShow less
    • Enrollment target: 15 to 30
    • Primary completion date: Dec 2025 to Aug 2027
    • Study completion date: Dec 2029 to Aug 2032
    • Study sites revised (10)
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 4 words
    • Study title expanded, about 4 words
  5. Study sites: 11 to 10v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 12 to 11v11
  2. Site details revised at 1 of 12 sitesv10
  3. Site details revised at 5 of 12 sitesv9
  4. Site details revised at 1 of 12 sitesv8
  5. Start date changed from estimate of Sep 2023 to Aug 10, 2023
    • Site details revised at 2 of 12 sites
    v7
  6. Start date: Jun 30, 2023 to Sep 2023v6
  7. Study sites: 13 to 12v5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 13
    • Start date changed from estimate of Jun 2023 to Jun 30, 2023
    v4
  9. Re-verified, no change to tracked fieldsv3
  10. Secondary endpoints: details revised at 1 of 1 entry
    • Study title shortened, about 4 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT05836259
Lead Sponsor Tenaya Therapeutics
Conditions
(from sponsor)		 Hypertrophic Cardiomyopathy
Related terms Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov