NCT04506645

Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	REGN5381	Single dose REGN5381 administered via IV infusion
OTHER	Placebo	Placebo matching single dose REGN 5381 administered via IV infusion

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2020-08-10
• Last updated: 2022-12-20

Locations

2 sites across 1 country: Belgium