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COMPLETED
NCT05353166
PHASE2

REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

REGN5381

Single dose administered via IV infusion

DRUG

Matching Placebo

Single dose administered via IV infusion

Locations (1)

ARENSIA Exploratory Medicine at the Republican Clinical Hospital

Chisinau, Moldova