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This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCAF5352A | Drug | may receive up to 3 subcutaneous doses of MCAF5352A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to approximately 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic: maximum serum concentration (Cmax) | up to approximately 100 days | |
| Pharmacokinetic: time to maximum serum concentration (tmax) | up to approximately 100 days | |
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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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| Placebo |
| Drug |
may receive up to 3 subcutaneous doses of placebo |
|
| Pharmacokinetic: apparent clearance (CL/F) |
| up to approximately 100 days |
| Pharmacokinetic: Terminal half-life (t½) | up to approximately 100 days |