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To Assess Safety, PK of Inhaled Voriconazole (ZP-059) Single Doses in Healthy Subjects (Part 1), ZP-059 Multiple Doses in Stable Asthma (Part 2) and in a Crossover Trial of ZP-059 and Oral Voriconazole Single Doses in Stable Asthma (Part 3)

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To Assess Safety, PK of Inhaled Voriconazole (ZP-059) Single Doses in Healthy Subjects (Part 1), ZP-059 Multiple Doses in Stable Asthma (Part 2) and in a Crossover Trial of ZP-059 and Oral Voriconazole Single Doses in Stable Asthma (Part 3)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2021

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At a glance

  • Drugs Voriconazole (Primary) ; Voriconazole (Primary)
  • Indications Asthma
  • Focus Adverse reactions
  • Sponsors Zambon SpA

    • Most Recent Events

    • 12 Nov 2021 Number of treatment arms have been increased from 2 to 9 by the addition of distinct experimental doses 5 mg, 10 mg, 20 mg, 40 mg in SAD cohorts and 10 mg bid, 20 mg bid, 40 mg qd in MAD cohorts and 20 mg single inhaled dose and 200 mg single oral dose in the crossover treatment period. Only "AR" is the trial focus now, retaining only "TEAEs" as primary end point, removing all the other ones.
    • 24 Sep 2020 Status changed from recruiting to completed.
    • 05 Mar 2020 Status changed from not yet recruiting to recruiting.

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