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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: REGN5381; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04506645

2020-000940-75 (EudraCT Number)

R5381-HV-1987

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

REGN5381

Experimental group

Description:

Single dose REGN5381 administered via IV infusion

Treatment:

Drug: REGN5381

Placebo

Other group

Description:

Placebo matching single dose REGN 5381 administered via IV infusion

Treatment:

Other: Placebo