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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000940-75 | EudraCT Number |
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The primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults.
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN5381 | Experimental | Single dose REGN5381 administered via IV infusion |
|
| Placebo | Other | Placebo matching single dose REGN 5381 administered via IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5381 | Drug | Single dose REGN5381 administered via IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to Day 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Systolic Blood Pressure (SBP) | Up to Day 78 | |
| Change from baseline in Diastolic Blood Pressure (DBP) | Up to Day 78 | |
| Change from baseline in Mean Arterial Pressure (MAP) |
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Inclusion Criteria:
1. Normal or mildly elevated blood pressure as defined in the protocol
Exclusion Criteria:
NOTE: Additional 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 |
|---|---|---|---|---|---|---|
| Ghent University | Ghent | 9000 | Belgium | |||
| Universitair Ziekenhuis Leuven Gasthuisberg Campus |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
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| Placebo |
| Other |
Placebo matching single dose REGN 5381 administered via IV infusion |
|
| Baseline to Day 4 |
| Change from baseline in Pulse Pressure (PP) | Baseline to Day 4 |
| Change from baseline in Heart Rate (HR) | Up to Day 78 |
| Change from baseline in Stroke Volume (SV) | Baseline to Day 4 |
| Maximum change from baseline in SBP across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Maximum change from baseline in DBP across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Maximum change from baseline in MAP across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Maximum change from baseline in PP across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Maximum change from baseline in HR across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Maximum change from baseline in SV across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) |
| Change from baseline in the 24-hour mean SBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose | Baseline 24-hour mean SBP is measured from 0 to 24 hours pre-dose | Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose |
| Change from baseline in the 24-hour mean DBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose | Baseline 24-hour mean DBP is measured from 0 to 24 hours pre-dose | Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose |
| Change from baseline in the 24-hour mean MAP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose | Baseline 24-hour mean MAP is measured from 0 to 24 hours pre-dose | Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose |
| Change from baseline in the 24-hour mean PP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose | Baseline 24-hour mean PP is measured from 0 to 24 hours pre-dose | Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose |
| Change from baseline in the 24-hour mean HR measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose | Baseline 24-hour mean HR is measured from 0 to 24 hours pre-dose | Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose |
| Concentrations of REGN5381 over time | Up to Day 78 |
| Number of subjects who develop anti-drug antibodies (ADA) and titers | Up to Day 78 |
| Percentage of subjects who develop anti-drug antibodies (ADA) and titers | Up to Day 78 |
| Leuven |
| B-3000 |
| Belgium |