Last updated on January 2017

Voclosporin in Healthy Japanese Volunteers

Brief description of study

The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin.

Detailed Study Description

Ten subjects will be randomized into each of four treatment groups to receive approximately 0.25, 0.5, 1.0, 1.5mg/kg/dose of voclosporin vs placebo. For Day 1, subjects will be given oral treatment once a day; Day 2, subjects will not be given any oral treatment; Day 3-12, subjects will be given oral treatment twice a day; Day 13, subjects will be given oral treatment once a day. The duration of the study takes about 21 days (including follow up assessments).

Clinical Study Identifier: NCT02949999

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