drugset / Trial / NCT02711423

A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers

NCT02711423

Phase 1 Completed 18 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.

Timeline

Start
2016-03-31
Primary completion
2016-09-28
Completion
2016-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Gantenerumab Monoclonal antibody Subcutaneous

Indications

No indication recorded.