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REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication for right heart catheterization (RHC). The aim of the study is to evaluate the safety and tolerability of the study drug. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN5381, an NPR1 Agonist, in Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2022-06-30
Completion Date
2025-06-02
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
REGN5381
Single dose administered via IV infusion
Matching Placebo
Single dose administered via IV infusion
Locations (1)
ARENSIA Exploratory Medicine at the Republican Clinical Hospital
Chisinau, Moldova