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This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RO5469754 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single doses, iv or sc |
| |
| RO5469754 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 72/120 hours post-dose, and at follow-up |
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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 |
|---|---|---|---|---|---|---|
| Groningen | 9728 NZ | Netherlands |
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| Drug |
Single ascending doses, iv or sc |
|