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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Single dose REGN5381 administered via IV infusion
Placebo matching single dose REGN 5381 administered via IV infusion
Ghent University
Ghent, Belgium
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Belgium
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to Day 78
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Up to Day 78
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Up to Day 78
Change from baseline in Mean Arterial Pressure (MAP)
Time frame: Baseline to Day 4
Change from baseline in Pulse Pressure (PP)
Time frame: Baseline to Day 4
Change from baseline in Heart Rate (HR)
Time frame: Up to Day 78
Change from baseline in Stroke Volume (SV)
Time frame: Baseline to Day 4
Maximum change from baseline in SBP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in DBP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in MAP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in PP across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in HR across the first 24 hours postdose
Time frame: Baseline to Day 2 (24-hours post dose)
Maximum change from baseline in SV across the first 24 hours postdose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Concentrations of REGN5381 over time
Time frame: Up to Day 78
Number of subjects who develop anti-drug antibodies (ADA) and titers
Time frame: Up to Day 78
Percentage of subjects who develop anti-drug antibodies (ADA) and titers
Time frame: Up to Day 78
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