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

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

Recruiting
Phase of Trial: Phase I

Latest Information Update: 14 Feb 2017

At a glance

  • Drugs Voclosporin (Primary)
  • Indications Lupus nephritis
  • Focus Adverse reactions
  • Sponsors Aurinia Pharmaceuticals
  • Most Recent Events

    • 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).
    • 14 Feb 2017 Results published in an Aurinia Pharmaceuticals Media Release
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