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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002568-34 | EudraCT Number |
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The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants
The secondary objectives of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Cohorts | Experimental | Randomized 6:2 to REGN9933 or placebo |
|
| Subcutaneous Cohorts | Experimental | Randomized 6:2 to REGN9933 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN9933 | Drug | Administered intravenously (IV) or subcutaneous (SC) per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events (TEAE) | Until resolution of pharmacodynamic (PD) effects; approximately 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in activated partial thromboplastin time (aPTT) | Until resolution of PD effects; approximately 36 days | |
| Change from baseline in prothrombin time (PT) | Until resolution of PD effects; approximately 36 days |
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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 | Edegem | Antwerp | B-2650 | Belgium |
| 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:
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| Placebo | Drug | Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol |
|
| Concentration of REGN9933 in serum | Until resolution of PD effects; approximately 36 days |
| Change from baseline in total Factor XI (FXI) concentrations | Until resolution of PD effects; approximately 36 days |
| The incidence of antidrug antibodies (ADAs) to REGN9933 over time | Until resolution of PD effects; approximately 36 days |