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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002012-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose regimen 1 of REGN3500 (IV) versus placebo |
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| Cohort 2 | Experimental | Dose regimen 2 of REGN3500 (IV) versus placebo |
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| Cohort 3 | Experimental | Dose regimen 3 of REGN3500 (IV) versus placebo |
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| Cohort 4 | Experimental | Dose regimen 4 of REGN3500 (SC) versus placebo |
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| Cohort 5 | Experimental | Dose regimen 5 of REGN3500 (IV) versus placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3500 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500 | Up to 293 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500 | Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing | |
| Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34523807 | Derived | Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29. |
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| ID | Term |
|---|---|
| C000720033 | itepekimab |
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| Drug |
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| Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing |
| Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500 | Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing |