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A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)

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Trial Profile

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs EDP 514 (Primary) ; EDP-721 (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions
  • Sponsors Enanta Pharmaceuticals

    • Most Recent Events

    • 18 Nov 2021 According to an Enanta Pharmaceuticals media release, the company announced that it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers.
    • 18 Nov 2021 Status changed from recruiting to discontinued according to an Enanta Pharmaceuticals media release.
    • 16 Aug 2021 According to an Enanta Pharmaceuticals media release, first patient has been dosed in this study. Data from the first part of the study are expected in the first half of 2022.

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