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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005132-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I (Dose Escalation): Gantenerumab | Experimental | Participants will receive a single SC dose of gantenerumab on Day 1. |
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| Part I (Dose Escalation): Placebo | Placebo Comparator | Participants will receive a single SC dose of matching placebo on Day 1. |
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| Part II (PK Extension): Gantenerumab | Experimental | Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events (AEs) | Up to 12 weeks (from Baseline to Day 85 +/- 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of gantenerumab | Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 | |
| Area under the plasma concentration-time curve (AUC) of gantenerumab |
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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 |
|---|---|---|---|---|---|---|
| Bioclinica Research | Orlando | Florida | 32806 | United States |
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| Placebo | Drug | Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1. |
|
| Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 |
| ID | Term |
|---|---|
| C571128 | gantenerumab |
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