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A Phase 1, Randomized, Open-Label, Sponsor-Open, Two-Sequence, Two-Period Crossover Study to Investigate the Bioequivalence of a Single Subcutaneous Dose of BMN 111 Administered Using Either a Vial and Syringe or Injector Pen in Healthy Adult Participants

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Trial Profile

A Phase 1, Randomized, Open-Label, Sponsor-Open, Two-Sequence, Two-Period Crossover Study to Investigate the Bioequivalence of a Single Subcutaneous Dose of BMN 111 Administered Using Either a Vial and Syringe or Injector Pen in Healthy Adult Participants

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs Vosoritide (Primary)
  • Indications Achondroplasia; Short stature
  • Focus Pharmacokinetics
  • Sponsors BioMarin Pharmaceutical

Most Recent Events

  • 10 Oct 2023 Status changed from recruiting to discontinued, as further optimization of the approach to achieve bioequivalence is required. The study termination was not due to any patient safety concerns.
  • 18 Apr 2023 New trial record

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