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SAD of IVT PYC-001 in OPA1 Mutation-Associated Autosomal Dominant Optic Atrophy (Sundew)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 1 month later Aug 2026 → Oct 2029
See other at-risk trials from PYC Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Oct 2029
    • Study completion pushed from Aug 2026 to Nov 2029
    • Eligibility criteria expanded, about 10 words
    • Study description shortened, about 25 words
  2. Primary completion date: Jul 2025 to Aug 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 2025 to Aug 2026
    • Site details revised at 2 of 2 sites
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Site contacts updated at 1 of 2 sitesv6
  5. Study sites: 1 to 2v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site contact updatedv4
  2. Site contact updatedv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Oct 31, 2024
    • Study sites: 0 to 1
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A First-in-Human multi-centre, prospective, Phase1a, Single Ascending Dose (SAD) interventional study of PYC-001 in participants with confirmed OPA1 mutation (haploinsufficiency) associated ADOA.
Trial Details
NCT Number NCT06461286
Lead Sponsor PYC Therapeutics
Conditions
(from sponsor)		 OPA1 Gene Mutation, Autosomal Dominant Optic Atrophy, Hereditary Optic Atrophies, Kjer Optic Atrophy
Related terms Optic Atrophies, Hereditary, Optic Atrophy, Autosomal Dominant
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov