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A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers

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Trial Profile

A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Voclosporin (Primary)
  • Indications Lupus nephritis; Nephrotic syndrome
  • Focus Adverse reactions
  • Sponsors Aurinia Pharmaceuticals

Most Recent Events

  • 12 Jan 2018 Status changed from recruiting to completed.
  • 14 Feb 2017 According to an Aurinia Pharmaceuticals Media Release, company is planning to share data from this study with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Q2 for for regulatory submission in Japan.
  • 14 Feb 2017 According to an Aurinia Pharmaceuticals Media Release, data from this study supports use of the 23.7mg BID voclosporin dose for Phase III (see profile 271230).

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