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A Phase I/IIa, Double-Blind, Placebo-Controlled Study Validating the Safety, Pharmacokinetics and Pharmacodynamic Profile of Sarconeos in Paediatric Patients with Duchenne Myopathy (MYODA-PK)

Trial Profile

A Phase I/IIa, Double-Blind, Placebo-Controlled Study Validating the Safety, Pharmacokinetics and Pharmacodynamic Profile of Sarconeos in Paediatric Patients with Duchenne Myopathy (MYODA-PK)

Planning
Phase of Trial: Phase I/II

Latest Information Update: 22 Oct 2018

At a glance

  • Drugs Sarconeos (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Pharmacokinetics
  • Acronyms MYODA-PK
  • Sponsors Biophytis
  • Most Recent Events

    • 22 Oct 2018 According to a Biophytis media release, The company has requested scientific advice from the FDA and EMA regarding the clinical program, and expects to obtain regulatory approvals for the MYODA-PK study of safety and pharmacokinetics in patients in S1 2019.
    • 13 Sep 2018 According to a Biophytis media release, MYODA clinical program in Duchenne myopathy, is expected to be authorized by the FDA before the end of 2018.
    • 28 Mar 2018 According to a Biophytis media release, this study could be launched in the second half of 2018.
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