Healthy
Conditions
Keywords
Normal Blood Pressure (BP), Mildly Elevated BP
Brief summary
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: * To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart rate (HR) in healthy normotensive and otherwise healthy hypertensive adults * To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV) * To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381 * To evaluate the immunogenicity of single IV doses of REGN5381
Interventions
DRUGREGN5381
Single dose REGN5381 administered via IV infusion
OTHERPlacebo
Placebo matching single dose REGN 5381 administered via IV infusion
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Normal or mildly elevated blood pressure as defined in the protocol
Exclusion criteria
1. History of cardiovascular disease as defined in the protocol 2. Protocol-defined risk factors for cardiovascular disease 3. History of unexplained syncope, autonomic dysfunction, or neurologic disease. NOTE: Additional Inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events | Up to Day 78 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Diastolic Blood Pressure (DBP) | Up to Day 78 | — |
| Change from baseline in Mean Arterial Pressure (MAP) | 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) | — |
| Change from baseline in Systolic Blood Pressure (SBP) | Up to Day 78 | — |
| 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 to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose | Baseline 24-hour mean SBP is measured from 0 to 24 hours pre-dose |
| 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 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 |
| 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 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 |
| 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 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 |
| 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 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 |
| 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 | — |
| Maximum change from baseline in HR across the first 24 hours postdose | Baseline to Day 2 (24-hours post dose) | — |
Countries
Belgium
Outcome results
None listed