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The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Dose Level 1 | Experimental | Randomized 6:2 for single ascending IV dose |
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| IV Dose Level 2 | Experimental | Randomized 6:2 for single ascending IV dose |
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| IV Dose Level 3 | Experimental | Randomized 6:2 for single ascending IV dose |
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| IV Dose Level 4 | Experimental | Randomized 6:2 for single ascending IV dose |
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| IV Dose Level 5 | Experimental | Randomized 6:2 for single ascending IV dose |
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| IV Dose Level 6 | Experimental | Randomized 6:2 for single ascending IV dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7544 | Drug | Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Through approximately day 162 | |
| Severity of TEAEs | Through approximately day 162 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in Systolic Blood Pressure (SBP) | Through day 6 | |
| Changes from baseline in Diastolic Blood Pressure (DBP) | Through day 6 | |
| Changes from baseline in Mean Arterial Pressure (MAP) |
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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 |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Christchurch | 8011 | New Zealand |
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 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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| SC Dose Level 1 | Experimental | Randomized 6:2 for single ascending SC dose |
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| SC Dose Level 2 | Experimental | Randomized 6:2 for single ascending SC dose |
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| SC Dose Level 3 | Experimental | Randomized 6:2 for single ascending SC dose |
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| Optional Cohort 1 | Experimental | Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level |
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| Optional Cohort 2 | Experimental | Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level |
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| Matching Placebo | Drug | Solution for single ascending IV or SC administration per the protocol |
|
| Through day 6 |
| Changes from baseline in Pulse Pressure (PP) | Through day 6 |
| Concentrations of REGN7544 in serum over time | Through approximately day 162 |
| Incidence of treatment-emergent Anti-Drug Antibody (ADA) | Through approximately day 162 |
| Titer of ADA | Through approximately day 162 |