drugset / Trial / NCT02711423
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gantenerumab | Monoclonal antibody | — | Subcutaneous |
Indications
No indication recorded.