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

• Status: Recruiting
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

1. Normal or mildly elevated blood pressure as defined in the protocol

Exclusion Criteria:

1. History of cardiovascular disease as defined in the protocol

2. Protocol-defined risk factors for cardiovascular disease

3. History of unexplained syncope, autonomic dysfunction, or neurologic disease.

NOTE: Additional Inclusion / Exclusion criteria apply