A phase I single- and multiple-ascending doses trial of AM 125 in healthy subjects.

Trial Profile

A phase I single- and multiple-ascending doses trial of AM 125 in healthy subjects.

Planning
Phase of Trial: Phase I

Latest Information Update: 28 Nov 2017

At a glance

  • Drugs Betahistine (Primary)
  • Indications Otitis
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 28 Nov 2017 According to an Auris Medical media release, the company has received feedback from the US FDA through Pre-IND meeting and from two European health authorities which has been incorporated in the development plans for AM-125 including this trial. The company expects to start enrolling subjects in this trial during the first quarter of 2018.
    • 20 Jul 2017 According to an Auris Medical media release, outcomes from this study will inform dose selection and regimen for a subsequent Phase 2 proof-of-concept trial.
    • 20 Jul 2017 According to an Auris Medical media release, the company plans to initiate this trial in the fourth quarter of 2017.
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