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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005174-26 | EudraCT Number |
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The primary objective of the study is to:
• Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.
The secondary objectives of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration. |
|
| Part B | Experimental | Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN9035 | Drug | Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) | Up to Day 162 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean systolic blood pressure (SBP) obtained after study drug administration | Up to 24 hours after study drug administration. | Up to Day 3 |
| Mean diastolic blood pressure (DBP) obtained after study drug administration |
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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 |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven Gasthuisberg Campus | Leuven | B-3000 | Belgium | |||
| Charite Research Organisation GmbH |
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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| REGN5381 | Drug | Part B: Selected doses administered by IV infusion on day 1. |
|
| Placebo | Other | Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22. |
|
| Up to Day 3 |
| Mean arterial pressure (MAP) obtained after study drug administration | Up to Day 3 |
| Mean pulse pressure (PP) obtained after study drug administration | Up to Day 3 |
| Mean pulse rate (PR) obtained after study drug administration | Up to Day 3 |
| Mean stroke volume (SV) obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean SBP obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean DBP obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean MAP obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean PP obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean PR obtained after study drug administration | Up to Day 3 |
| Absolute change in the mean SV obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean SBP obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean DBP obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean MAP obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean PP obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean PR obtained after study drug administration | Up to Day 3 |
| Maximum change in the mean SV obtained after study drug administration | Up to Day 3 |
| Percent change in the mean SBP obtained after study drug administration | Up to Day 3 |
| Percent change in the mean DBP obtained after study drug administration | Up to Day 3 |
| Percent change in the mean MAP obtained after study drug administration | Up to Day 3 |
| Percent change in the mean PP obtained after study drug administration | Up to Day 3 |
| Percent change in the mean PR obtained after study drug administration | Up to Day 3 |
| Percent change in the mean SV obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration | Up to Day 3 |
| Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration | Up to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration. | Baseline to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration. | Baseline to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration. | Baseline to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration. | Baseline to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration. | Baseline to Day 3 |
| Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration. | Baseline to Day 3 |
| Time to return to within 10% of baseline (pre-REGN5381) SBP | Up to approximately Day 162 |
| Time to return to within 10% of baseline (pre-REGN5381) DBP | Up to approximately Day 162 |
| Time to return to within 10% of baseline (pre-REGN5381) MAP | Up to approximately Day 162 |
| Time to return to within 10% of baseline (pre-REGN5381) PP | Up to approximately Day 162 |
| Time to return to within 10% of baseline (pre-REGN5381) PR | Up to approximately Day 162 |
| Time to return to within 10% of baseline (pre-REGN5381) SV | Up to approximately Day 162 |
| SBP | Through Day 36 |
| DBP | Through Day 36 |
| MAP | Through Day 36 |
| PP | Through Day 36 |
| PR | Through Day 36 |
| Absolute change from baseline in SBP | Through Day 36 |
| Absolute change from baseline in DBP | Through Day 36 |
| Absolute change from baseline in MAP | Through Day 36 |
| Absolute change from baseline in PP | Through Day 36 |
| Absolute change from baseline in PR | Through Day 36 |
| Percent change from baseline in SBP | Through Day 36 |
| Percent change from baseline in DBP | Through Day 36 |
| Percent change from baseline in MAP | Through Day 36 |
| Percent change from baseline in PP | Through Day 36 |
| Percent change from baseline in PR | Through Day 36 |
| Concentrations of total REGN9035 | Up to Day 162 |
| Concentrations of total REGN5381 over time | Up to Day 162 |
| Concentrations of total REGN9035 and/or total REGN5381 | Up to Day 162 |
| Berlin |
| 10117 |
| Germany |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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