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The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose 1 of REGN1908-1909 or placebo |
|
| Cohort 2 | Experimental | Dose 2 of REGN1908-1909 or placebo |
|
| Cohort 3 | Experimental | Dose 3 of REGN1908-1909 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1908-1909 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study). | day 1 to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration | The secondary endpoint is serum concentrations of REGN1908-1909 over time. | day 1 to day 113 |
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Inclusion Criteria:
Exclusion Criteria:
The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34437752 | Derived | Kamal MA, Dingman R, Wang CQ, Lai CH, Rajadhyaksha M, DeVeaux M, Orengo JM, Radin A, Davis JD. REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. Clin Transl Sci. 2021 Nov;14(6):2440-2449. doi: 10.1111/cts.13112. Epub 2021 Aug 26. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Other |
|
| Baltimore |
| Maryland |
| United States |