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A Phase I/II Trial of JR-446 in Mucopolysaccharidosis Type IIIB (MPS IIIB)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 13 words
    • Site details revised at 5 of 5 sites
  2. Start date pushed from Sep 4, 2026 to Sep 9, 2026v5
  3. Start date: Jun 18, 2026 to Sep 4, 2026v4
  4. Study sites: 4 to 5v3
  5. Study sites: 5 to 4v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 global, open-label, Phase I/II, interventional trial in participants younger than 6 years of age with Mucopolysaccharidosis Type IIIB (MPS IIIB), designed to assess the safety and tolerability of JR-446, determine its pharmacodynamic effects, and explore its potential to demonstrate early clinical effects on disease-relevant outcomes.
Trial Details
NCT Number NCT07640984
Lead Sponsor JCR Pharmaceuticals Co., Ltd.
Collaborators: MEDIPAL HOLDINGS CORPORATION
Conditions
(from sponsor)		 Mucopolysaccharidosis IIIB
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov