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A Phase I/IIa Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Macuneos in Healthy Volunteers and Patients with Dry Age-Related Macular Degeneration (Dry AMD)

Trial Profile

A Phase I/IIa Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Macuneos in Healthy Volunteers and Patients with Dry Age-Related Macular Degeneration (Dry AMD)

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 26 Jun 2019

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At a glance

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

    • 26 Jun 2019 According to a Biophytis media release, the preclinical results and initial discussion regarding the potential design of the phase 1 clinical trial support the companys plan to hold a scientific advice meeting with EU regulatory agencies in the second half of 2019 regarding clinical development of Macuneos (BIO201) for the potential treatment of dry AMD and Stargardt disease.
    • 26 Jun 2019 According to a Biophytis media release, guiding principles regarding the clinical design of a phase 1 trial for Macuneos (BIO201) in healthy volunteers was presented by Serge Camelo of Biophytis at the MaculART meeting (Paris, France, June 24th, 2019).
    • 22 Oct 2018 According to a Biophytis media release, the company intends to request scientific advice from the FDA and EMA in Q1 2019, and to obtain regulatory approvals for the MACA-PK study of safety and pharmacokinetics in healthy volunteers in S1 2019.
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