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Primary Objective: Determine blood concentrations of two formulations of REGN1033.
Secondary Objective: Assess safety and tolerability of REGN1033.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Drug | Experimental | REGN1033 Reference Formulation |
|
| Test Drug | Experimental | REGN1033 Test Formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum REGN1033 concentration-time curve (AUC) | Pre-dose to day 57 | |
| Peak REGN1033 concentration (Cmax) | Pre-dose to day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) from baseline to the end of the study | Day 1 to end of study (Day 57) | |
| Presence or absence of anti-drug antibody (ADA) | Day 1 to end of study (Day 57) |
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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 |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
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