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A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs EDP 305 (Primary)
  • Indications Non-alcoholic fatty liver disease
  • Focus Adverse reactions; First in man
  • Sponsors Enanta Pharmaceuticals

Most Recent Events

  • 14 Apr 2018 Results assessing safety of EDP-305 in healthy volunteers and presumptive NAFLD subjects, presented at The International Liver Congress 2018.
  • 12 Apr 2018 According to an Enanta Pharmaceuticals media release, data from this trial will be presented at The International Liver Congres 2018
  • 07 Feb 2018 According to an Enanta Pharmaceuticals media release, data from this trial was presented at the 2018 NASH-TAG conference in Park City, Utah, January 4-6, 2018.

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