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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515285-14-00 | EU Trial (CTIS) Number |
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The aim of this clinical trial is to see how safe and tolerable the clinical trial drug (REGN9533) is in healthy participants. This is the first time that REGN9533 will be given to humans.
After the clinical trial drug has been tested in healthy participants, future studies with REGN9533 will focus on participants with thromboembolic (blocking of blood vessels) diseases which include blood clots.
REGN9533 is a drug that is only used in clinical studies.
The clinical trial is looking at:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN9533 | Experimental | Randomized as described in the protocol Escalating Cohorts including Optional Cohorts |
|
| Placebo | Experimental | Randomized as described in the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN9533 | Drug | Administered per the protocol |
| |
| Matching Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Up to 100 days | |
| Severity of TEAEs | Up to 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in activated Partial Thromboplastin Time (aPTT) | Baseline up to 100 days | |
| Change in Prothrombin Time (PT) | Baseline up to 100 days | |
| Concentrations of REGN9533 |
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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 |
|---|---|---|---|---|---|---|
| SGS Belgium NV_Edegem | Edegem | Antwerp | 2650 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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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| Drug |
Administered per the protocol. |
|
| Up to 100 days |
| Incidence of Anti-drug Antibodies (ADAs) to REGN9533 | Up to 100 days |
| Titer of ADAs to REGN9533 | Up to 100 days |