drugset / Trial / NCT04506645
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REGN5381 | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.