drugset / Trial / NCT02133937

A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers

NCT02133937

Phase 1 Completed 31 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.

Timeline

Start
2014-04
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gantenerumab Monoclonal antibody Subcutaneous

Indications

No indication recorded.