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A Phase 1/2 First-in-human, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1: Open-label) and Repeat Doses (Part 2: Randomized, Double-blind, Placebo-controlled) of UX053 in Patients With GSD III

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Trial Profile

A Phase 1/2 First-in-human, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1: Open-label) and Repeat Doses (Part 2: Randomized, Double-blind, Placebo-controlled) of UX053 in Patients With GSD III

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 19 Apr 2024

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At a glance

  • Drugs UX 053 (Primary) ; Cetirizine; Dexamethasone; Famotidine; Ibuprofen; Paracetamol
  • Indications Glycogen storage disease type III
  • Focus Adverse reactions; First in man
  • Acronyms UX053-CL101
  • Sponsors Ultragenyx Pharmaceutical

Most Recent Events

  • 04 May 2023 According to an Ultragenyx Pharmaceutical media release, company has decided to not enroll patients in the multiple ascending dose cohorts at this time to allow greater focus on other late-stage and larger indication clinical programs. The data from the SAD cohort are being analyzed and are expected in the second quarter of 2023.
  • 30 Mar 2023 Status changed from active, no longer recruiting to discontinued.
  • 16 Feb 2023 Planned End Date changed from 1 Jun 2024 to 1 Mar 2023.

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