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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006093-65 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCLF | Experimental |
| |
| LyoF | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gantenerumab | Drug | High concentration liquid formulation (HCLF), single dose sc |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability: Area under the concentration-time curve | Pre-dose and up to 85 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 8 months | |
| Dose-exposure relationship | approximately 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | 35042 | France |
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| ID | Term |
|---|---|
| C571128 | gantenerumab |
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| gantenerumab |
| Drug |
Lyophilized formulation (LyoF), single dose sc |
|