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A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis

Trial Profile

A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 31 Oct 2019

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At a glance

  • Drugs MRT-5005 (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; First in man
  • Acronyms RESTORE-CF
  • Sponsors Translate Bio
  • Most Recent Events

    • 31 Oct 2019 According to a Translate Bio media release, interim results (n=12) from the single-ascending dose portion of this study will be presented at the 33rd Annual North American Cystic Fibrosis Conference (NACFC) taking place in Nashville, Tennessee from October 31 to November 2, 2019.
    • 27 Feb 2019 According to a Translate Bio media release, the compaany announced that based on previous approval by the Protocol Review Safety Committee, the trial has now advanced to dosing patients in the MAD portion of the trial while continuing to progress through increasing doses in the SAD portion of the trial. The Company remains on track to report interim data from the clinical trial in the second half of 2019.
    • 09 Aug 2018 According to a Translate Bio media release, study will Initiate multiple-ascending dose portion of the Phase 1/2 clinical trial by year end 2018.
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