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A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Determine the Safety, Pharmacokinetics, Food, and Fecal Microbiome Effects of ACX-362E Administered Orally to Healthy Subjects

Trial Profile

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Determine the Safety, Pharmacokinetics, Food, and Fecal Microbiome Effects of ACX-362E Administered Orally to Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Nov 2022

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At a glance

  • Drugs Ibezapolstat (Primary) ; Vancomycin
  • Indications Clostridium difficile infections
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Acurx Pharmaceuticals
  • Most Recent Events

    • 26 Oct 2022 According to an Acurx Pharmaceuticals media release, data from this study will be presented at the Infectious Disease Society of America (IDSA) IDWeek 2022 Conference.
    • 17 Oct 2022 According to an Acurx Pharmaceuticals media release, data from this study will be presented at the Infectious Disease Society of America (IDSA) IDWeek 2022 Conference
    • 06 Jul 2022 Results (n=22) assessing microbiome changes as well as the bile acid changes associated with ibezapolstat compared to those associated with vancomycin by using samples obtained from this study, published in the Antimicrobial Agents and Chemotherapy
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