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A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

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Trial Profile

A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Fosmanogepix (Primary)
  • Indications Aspergillosis; Candidiasis; Mycoses
  • Focus Adverse reactions; First in man
  • Sponsors Basilea Pharmaceutica; Pfizer

    • Most Recent Events

    • 26 Oct 2023 Interventional study model changed from Parallel to Sequential.
    • 29 Mar 2023 Results assessing safety and pharmacokinetics of Intravenous and oral fosmanogepix in healthy volunteers from NCT02957929 and NCT02956499 studies, published in the Antimicrobial Agents and Chemotherapy.
    • 09 Oct 2017 Results from this and another phase I trial presented in an Amplyx Pharmaceuticals media release.

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