drugset / Trial / NCT04506645

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

NCT04506645 ↗

Phase 1 Completed 90 enrolled Regeneron Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

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

Timeline

Start
2020-09-01
Primary completion
2022-12-14
Completion
2022-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject REGN5381 Protein / enzyme biologic — Intravenous

Indications

No indication recorded.