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The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN2477 | Experimental | Cohorts 1 - 5 will receive REGN2477 |
|
| Placebo | Experimental | Cohorts 1 - 5 will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2477 | Drug | Participants will receive ascending doses of REGN2477 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477 | Day 1 to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time | Day 1 to Day 113 | |
| Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time | Day 1 to Day 113 |
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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 |
|---|---|---|---|---|---|---|
| Antwerp | Belgium |
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| Placebo |
| Drug |
Participants will receive matching placebo |
|