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A Phase 1/2 Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered MRT5201 in Subjects With Ornithine Transcarbamylase Deficiency

Trial Profile

A Phase 1/2 Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered MRT5201 in Subjects With Ornithine Transcarbamylase Deficiency

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I/II

Latest Information Update: 18 Sep 2019

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At a glance

  • Drugs MRT-5201 (Primary)
  • Indications Ornithine carbamoyltransferase deficiency disease
  • Focus Adverse reactions; First in man
  • Acronyms STEP-OTC
  • Sponsors Translate Bio
  • Most Recent Events

    • 12 Sep 2019 Status changed from not yet recruiting to withdrawn prior to enrolment.
    • 26 Jun 2019 According to a Translate Bio media release, the U.S. Food and Drug Administration (FDA) has removed the clinical hold and allowed to proceed with a single-ascending dose trial after the discussions with the FDA and after amending the protocol.
    • 26 Jun 2019 Planned number of patients changed from 24 to 12.
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