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A Single-Center, Double-Blind, Placebo-Controlled, Phase 1b Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral Nafamostat Mesylate in Healthy Volunteers Subjects

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A Single-Center, Double-Blind, Placebo-Controlled, Phase 1b Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral Nafamostat Mesylate in Healthy Volunteers Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Nafamostat (Primary)
  • Indications COVID 2019 infections; Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions
  • Sponsors Ensysce Biosciences

    • Most Recent Events

    • 11 Oct 2021 Status changed from recruiting to completed.
    • 28 Sep 2020 According to an Ensysce Biosciences media release, this Phase 1 trial at the Arizona Research Center in Phoenix, Arizona under the direction of Dr. Joseph Gimbel, is examining nafamostat as an oral solution, a route of administration that has not been studied for this drug. The outcome will be to identify a dose and schedule for a subsequent Phase 2 trial in COVID-19 patients.
    • 28 Sep 2020 According to an Ensysce Biosciences media release, COVISTAT Inc. and its parent company Ensysce, received IND allowance and today initiated this Phase 1 clinical trial of oral nafamostat in healthy volunteers.

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