A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients

Trial Profile

A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients

Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 May 2017

At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Protalix Biotherapeutics
  • Most Recent Events

    • 10 May 2017 According to a Protalix Biotherapeutics media release, results from this trial were presented at the World Congress of Nephrology 2017, titled, The Fifth Update on Fabry Nephropathy.
    • 09 May 2017 Results of pharmacokinetic analysis and modeling, which provides a strong rationale for once-monthly dosing of PRX-102, published in a Protalix BioTherapeutics Media Release.
    • 16 Mar 2017 According to a Protalix Biotherapeutics media release, results from this trial were presented at the 13th Annual WORLDSymposium 2017.
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