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Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 4 sites
  2. Start date changed from estimate of Sep 2026 to Sep 16, 2026
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 1 of 4 sites
  3. Trial sites expanded: 1 → 4 locations
    • Start date: Aug 2026 to Sep 2026
    v3
  4. Recruitment opened
    • Start date: Jun 2026 to Aug 2026
    • Study sites: 0 to 1
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1. After the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion. For patients interested in additional information on how to participate, please follow this link: https://mytomorro.ws/ph1trial.
Trial Details
NCT Number NCT07587021
Lead Sponsor YolTech Therapeutics Co., Ltd
Conditions
(from sponsor)		 Primary Hyperoxaluria Type 1, PH1
Related terms Hyperoxaluria, Hyperoxaluria, Primary, Kidney Calculi, Primary hyperoxaluria type 1
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov