drugset / Trial / NCT01636531

A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers

NCT01636531

Phase 1 Completed 120 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-label

Summary

This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.

Timeline

Start
2012-05
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gantenerumab Monoclonal antibody Subcutaneous

Indications

No indication recorded.