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A Single-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety and Tolerability of PDNO Administered as an Intravenous Infusion in Healthy Subjects

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Trial Profile

A Single-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety and Tolerability of PDNO Administered as an Intravenous Infusion in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Jan 2023

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At a glance

  • Drugs Nitrosooxypropanol (Primary) ; Propylene glycols
  • Indications Pulmonary hypertension
  • Focus Adverse reactions; First in man
  • Sponsors Attgeno

    • Most Recent Events

    • 17 Jan 2023 Both the previous experimental and placebo arms have been replaced by Experimental: Part I: single ascending dose (SAD) and Experimental: Part II: ascending doses of PDNO arms. Study design has been changed from sequential to parallel.
    • 17 Jun 2022 Status changed from recruiting to completed.
    • 14 Feb 2022 Planned End Date changed from 15 Dec 2021 to 15 Jul 2022.

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