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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | (3:1, active:placebo) |
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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN668 | Biological | 4 IV Cohorts (Dose 1, 2, 3, & 4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11. | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Serum concentrations of REGN668 over time. | 85 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Radin | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32348036 | Derived | Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29. |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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