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A Phase I, randomized, double-blind, placebo-controlled single and multiple ascending dose program study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral LSD1-MAOB dual selective inhibitor ORY-2001 in healthy subjects

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Trial Profile

A Phase I, randomized, double-blind, placebo-controlled single and multiple ascending dose program study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral LSD1-MAOB dual selective inhibitor ORY-2001 in healthy subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 26 Mar 2021

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At a glance

  • Drugs Vafidemstat (Primary)
  • Indications Aggression; Alzheimer's disease; Autistic disorder; Multiple sclerosis; SARS-CoV-2 acute respiratory disease; Schizophrenia; Telomeric 22q13 Monosomy Syndrome
  • Focus Adverse reactions; First in man
  • Sponsors Oryzon

    • Most Recent Events

    • 24 Mar 2021 Results published in the Media Release
    • 23 Mar 2021 Results published in the CNS Drugs
    • 24 Jul 2017 According to an Oryzon media release, with the approval of the Spanish Medicines Agency (AEMPS), an additional cohort of volunteers was added to be administered at a higher dose of ORY-2001 to complete the hematological safety profile of the product, as well as two additional cohorts to determine the levels of the drug in cerebrospinal fluid.
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