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

NCT ID: NCT04506645

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-14

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Keywords

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Normal Blood Pressure (BP) Mildly Elevated BP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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REGN5381

Single dose REGN5381 administered via IV infusion

Group Type EXPERIMENTAL

REGN5381

Intervention Type DRUG

Single dose REGN5381 administered via IV infusion

Placebo

Placebo matching single dose REGN 5381 administered via IV infusion

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo matching single dose REGN 5381 administered via IV infusion

Interventions

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REGN5381

Single dose REGN5381 administered via IV infusion

Intervention Type DRUG

Placebo

Placebo matching single dose REGN 5381 administered via IV infusion

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Ghent University

Ghent, , Belgium

Site Status

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2020-000940-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R5381-HV-1987

Identifier Type: -

Identifier Source: org_study_id