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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002001-20 | EudraCT Number |
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This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
This study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Lowest IV Dose | Experimental | Randomized 3:1 |
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| Cohort 2 Low IV Dose | Experimental | Randomized 3:1 |
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| Cohort 3 Mid IV Dose | Experimental | Randomized 3:1 |
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| Cohort 4 High IV Dose | Experimental | Randomized 3:1 |
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| Cohort 5 Higher IV Dose | Experimental | Randomized 3:1 |
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| Cohort 6 High SC Dose | Experimental | Randomized 3:1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 (IV) | Drug | Administered sequential, ascending single intravenous (IV) dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidences of treatment-emergent adverse events (TEAE) | Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. | Up to 36 days |
| Severity of TEAE | Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. | Up to 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in activated partial thromboplastin time (aPTT) | Up to 36 days | |
| Change from baseline in prothrombin time (PT) | Up to 36 days | |
| Concentrations of total REGN7508 in serum |
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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 |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit | Leeds | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42275249 | Derived | Chalothorn D, Kithcart AP, Marin E, Somersan-Karakaya S, Lai K, Cauwberghs F, Ackroyd JPR, Mohammadi K, Shrestha A, Ehrlich GK, Rafique A, Chatterjee I, Saotome K, Franklin MC, Murphy AJ, Olson WC, Olenchock BA, Herman GA, Gutstein DE, Sirulnik A, Yancopoulos GD, Morton LG. Anticoagulation with mechanistically distinct FXI/FXIa antibodies amrecibart (REGN9933A2) and cenvacibart (REGN7508Cat). Blood. 2026 Jun 11:blood.2025032276. doi: 10.1182/blood.2025032276. Online ahead of print. |
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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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| Cohort 7 Higher SC Dose | Experimental | Randomized 3:1 |
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| Optional: Cohort 8 Highest IV or SC Dose | Experimental | Randomized 3:1 |
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| Cohort 9 High SC Dose | Experimental | Randomized 3:1 |
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| Optional: Cohort 10 Highest SC Dose | Experimental | Randomized 3:1 |
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| REGN7508 (SC) | Drug | Administered sequential, ascending single subcutaneous (SC) dose |
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| Matching Placebo (IV) | Drug | Administered sequential, ascending single intravenous (IV) dose |
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| Matching Placebo (SC) | Drug | Administered sequential, ascending single subcutaneous (SC) dose |
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| Up to 36 days |
| Concentrations of functional REGN7508 in plasma | Up to 36 days |
| Absolute concentration and change from baseline in total Factor XI (FXI) concentrations | Up to 36 days |
| Absolute concentration and change from baseline in free FXI concentrations | Up to 36 days |
| Incidence of antidrug antibodies (ADAs) to REGN7508 over time | Up to 36 days |