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An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee

Trial Profile

An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs FX 201 (Primary)
  • Indications Osteoarthritis; Pain
  • Focus Adverse reactions; First in man
  • Sponsors Flexion Therapeutics
  • Most Recent Events

    • 12 Nov 2019 Status changed from not yet recruiting to recruiting, according to an Flexion Therapeutics media release.
    • 31 Oct 2019 According to a Flexion Therapeutics media release, Javad Parvizi, MS, MD, FRC, orthopedic surgeon at the Rothman Institute is the principal investigator for the study.
    • 31 Oct 2019 According to a Flexion Therapeutics media release, the company has received clearance of the Investigational New Drug (IND) application for FX201 in knee osteoarthritis (OA). The study is expected to begin enrolling by year-end and expects to treat the first patient by the end of 2019. Initial clinical data anticipated in 2021.
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