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A Phase 1 Exploratory Placebo and Active-Controlled, Double-Blind, Single and Multiple-Dose Escalation, Pharmacokinetic, Pharmacodynamic and Food Effect Study of CNSA-001 in Healthy Volunteers

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Trial Profile

A Phase 1 Exploratory Placebo and Active-Controlled, Double-Blind, Single and Multiple-Dose Escalation, Pharmacokinetic, Pharmacodynamic and Food Effect Study of CNSA-001 in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Jul 2019

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At a glance

  • Drugs Sepiapterin (Primary) ; Sapropterin
  • Indications Dystonia; Phenylketonuria
  • Focus Adverse reactions; First in man
  • Sponsors Censa Pharmaceuticals Australia

    • Most Recent Events

    • 26 Jul 2018 Status changed from recruiting to completed, as reported in a Retrophin media release
    • 01 May 2018 According to a Retrophin media release, In the first quarter of 2018, the single ascending dose portion of this study had been completed and advanced into the multiple ascending dose portion of the study.
    • 17 Nov 2017 New trial record
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