drugset
drugset / Trial / NCT05291546

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants

NCT05291546 ↗

Phase 1 Completed 93 enrolled Regeneron Pharmaceuticals
RandomizedSequentialQuadruple-blindTreatment

Summary

The primary objective of the study is to: • Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially. The secondary objectives of the study are to: * Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381 * Evaluate the hemodynamic effects of single IV doses of REGN5381 * Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo) * Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially

Timeline

Start
2022-04-13
Primary completion
2024-04-02
Completion
2024-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject IMELCIMENT Protein / enzyme biologic — Intravenous
Subject REGN5381 Protein / enzyme biologic — Intravenous

Indications

No indication recorded.