Voclosporin in Healthy Japanese Volunteers

Volunteers Clinical Trial

Official title: 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

Clinical Trial Summary

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Volunteers

• NCT number: NCT02949999
• Study type: Interventional
• Source: Aurinia Pharmaceuticals Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Completion date: December 2016