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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Concentration Liquid Formulation (HCLF) | Experimental |
| |
| Lyophilized formulation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gantenerumab | Drug | Single subcutaneous injection of a high concentration liquid formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of gantenerumab | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Approximately 21 weeks |
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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 |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| gantenerumab | Drug | Single subcutaneous injection of a lyophilized formulation |
|
| ID | Term |
|---|---|
| C571128 | gantenerumab |
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