drugset / Trial / NCT02458677

Single Ascending Dose Study of PRX003 in Healthy Subjects

NCT02458677 ↗

Phase 1 Completed 40 enrolled Prothena Biosciences Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.

Timeline

Start
2015-05
Primary completion
2016-02
Completion
2016-02

Outcome

Met primary endpoint

release “All doses of PRX003 found to be safe and well tolerated, meeting the primary objective of the Phase 1 single ascending dose study in healthy volunteers” prothena.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject IMAPRELIMAB Monoclonal antibody — Intravenous

Indications