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First-in-human Study of UX016 in GNEM

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

Record History

  1. Recruitment opened Eligibility criteria expanded, about 18 words · Secondary endpoints: 4 to 7 · Study sites revised (2)v2 Show 3 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 4 to 7
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to assess the safety and dose of UX016 and its impact on muscle strength in adults with GNE Myopathy (GNEM).
Trial Details
NCT Number NCT07511556
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions GNE Myopathy
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov