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This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCAF5352A | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCAF5352A | Drug | Multiple ascending doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve | Pre-dose and 5 time points up to 14 days post-dose | |
| Immunogenicity: Serum MCAF5252A antibodies | Days 1, 29, 50, 78, 106 and 134 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Québec | Quebec | G1P 0A2 | Canada |
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| Drug |
Matching MCAF5352A, multiple doses |
|