Voclosporin in Healthy Japanese Volunteers
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Study ID
- NCT02949999
- Phase
- PHASE1
- Status
- Completed
Conditions
- Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Voclosporin — DRUG
Study Details
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.
Key Dates
- Start date
- Oct 31, 2016
- Status verified
- Jan 2018
- Primary completion
- Dec 31, 2016
- Completion
- Dec 31, 2016
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 0.25mg/kg voclosporin0.25mg/kg voclosporin BID.
- Experimental: 0.5mg/kg voclosporin0.5mg/kg voclosporin BID
- Experimental: 1.0mg/kg voclosporin1.0mg/kg voclosporin BID
- Experimental: 1.5mg/kg voclosporin1.5mg/kg voclosporin BID
- Placebo Comparator: Placebo voclosporinplacebo BID
Primary Outcome Measure
Incidence of treatment emergent adverse events [ Time Frame: 21 days ]