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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000182-41 | EudraCT Number |
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The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower IV Dose | Experimental | Randomized 3:1 |
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| Mid IV Dose 1 | Experimental | Randomized 3:1 |
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| Mid IV Dose 2 | Experimental | Randomized 3:1 |
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| Higher IV Dose | Experimental | Randomized 3:1 |
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| Lower SC Dose | Experimental | Randomized 3:1 |
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| Mid SC Dose | Experimental | Randomized 3:1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN15160 (IV) | Drug | Administered in single intravenous (IV) dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of all treatment emergent adverse events (TEAEs) | Through Day 169 | |
| Occurrence and severity of all serious adverse events (SAEs) | Through Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN15160 in serum | Through Day 169 | |
| Incidence and titer of anti-drug antibodies (ADA) to REGN15160 | Through Day 169 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Leuven | B-3000 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Higher SC Dose | Experimental | Randomized 3:1 |
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| Matching Placebo (IV) | Drug | Administered in single IV dose |
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| REGN15160 (SC) | Drug | Administered in single subcutaneous (SC) dose |
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| Matching Placebo (SC) | Drug | Administered in single SC dose |
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| ID | Term |
|---|---|
| C000722688 | REGN15160 |
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