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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Dose 1 REGN475 |
|
| Cohort 2 | Active Comparator | Dose 2 of REGN475 |
|
| Cohort 3 | Active Comparator | Dose 2 of REGN475 |
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| Cohort 4 | Active Comparator | Dose 1 of REGN475 |
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| Cohort 5 | Active Comparator | Dose 2 of REGN475 |
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| Cohort 6 | Active Comparator | Dose 1 REGN475 subcutaneous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN475 (SAR164877) | Biological | Subcutaneous administration REGN475 (SAR164877) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of REGN475. | 16 Weeks | |
| The presence or absence of antibodies against REGN475. | 16 Week follow up |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altoona | Pennsylvania | United States |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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| Cohort 7 |
| Active Comparator |
Dose 2 REGN475 subcutaneous administration |
|