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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | (3:1, active: placebo) |
|
| Dose 2 | Experimental | (3:1, active: placebo) |
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| Dose 3 | Experimental | (3:1, active: placebo) |
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| Dose 4 | Experimental | (3:1, active: placebo) |
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| Dose 5 | Experimental | (3:1, active: placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN846 | Biological | 5 IV cohorts (Dose 1, 2, 3, 4, 5) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Baseline through end of study |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile | Baseline through end of study | |
| Immunogenicity | Visits 2, 8, 10 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Australia |
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