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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003170-16 | EudraCT Number |
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This is a single center, randomized, investigator/subject blind, single ascending dose, placebo-controlled, parallel study that will evaluate the safety, tolerability and pharmacokinetics of RO6926496 in healthy male participants. The dose escalation is adaptive in nature. It is planned to enroll 48 subjects in 6 cohorts. The anticipated total duration of the study is 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 8 volunteers (6 active, 2 placebo) |
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| Cohort 2 | Experimental | 8 volunteers (6 active, 2 placebo) |
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| Cohort 3 | Experimental | 8 volunteers (6 active, 2 placebo) |
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| Cohort 4 | Experimental | 8 volunteers (6 active, 2 placebo) |
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| Cohort 5 | Experimental | 8 volunteers (6 active, 2 placebo) |
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| Cohort 6 | Experimental | 8 volunteers (6 active, 2 placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo to RO6926496 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile and parameters derived from serum concentrations of RO6926496 (composite outcome measure): area under the concentration-time curve (AUC), Cmax, tmax, clearance | Up to 16 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 |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| RO6926496 | Drug | single, ascending dose, intravenous administration |
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