A phase I/IIa study to evaluate the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers and then in patients suffering from dry AMD.

Trial Profile

A phase I/IIa study to evaluate the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers and then in patients suffering from dry AMD.

Planning
Phase of Trial: Phase I/II

Latest Information Update: 26 Jul 2018

At a glance

  • Drugs Macuneos (Primary)
  • Indications Dry age-related macular degeneration
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Acronyms MACA-PK
  • Most Recent Events

    • 26 Jul 2018 According to a Biophytis media release, the MAD portion of the study will be conducted in Europe. The study will commence in 2018 and is expected to complete in 2019.
    • 28 Mar 2018 According to a Biophytis media release, the regulatory approval process is underway and the Single Ascending Dose (SAD) phase of the study could begin this summer. The results of the SAD phase are expected before the end of the year.
    • 22 Jun 2017 New trial record
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