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A Phase 1, randomized, Double-Blind, Placebo-Controlled study to evaluate the Safety, Tolerability and Pharmacokinetics of single and multiple ascending doses of Ultramicronized PEA in normal healthy volunteers

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A Phase 1, randomized, Double-Blind, Placebo-Controlled study to evaluate the Safety, Tolerability and Pharmacokinetics of single and multiple ascending doses of Ultramicronized PEA in normal healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jul 2022

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At a glance

  • Drugs Palmitoylethanolamide (Primary)
  • Indications COVID 2019 infections; Fibromyalgia; Inflammation; Irritable bowel syndrome; Neurological disorders; Pain
  • Focus Adverse reactions; First in man
  • Sponsors FSD Pharma

    • Most Recent Events

    • 13 Jul 2022 According to a FSD Pharma media release, the company filed a provisional patent application on novel formulations of palmitoylethanolamide (PEA). The new patent application is based on the results of completed preclinical animal toxicology studies and this phase 1 clinical trial using FSD201 (ultramicronized PEA).
    • 22 Jun 2020 Results presented in the FSD Pharma media release.
    • 19 Jun 2020 Status changed from recruiting to completed, according to a FSD Pharma media release.

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