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

NCT04506645 | Completed Phase 1

• 2 other identifiers: R5381-HV-19872020-000940-75
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Healthy

Keywords

Normal Blood Pressure (BP); Mildly Elevated BP

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Up to Day 78

Secondary Outcomes (20)

• Change from baseline in Systolic Blood Pressure (SBP)

  Up to Day 78

• Change from baseline in Diastolic Blood Pressure (DBP)

  Up to Day 78

• Change from baseline in Mean Arterial Pressure (MAP)

  Baseline to Day 4

• Change from baseline in Pulse Pressure (PP)

  Baseline to Day 4

• Change from baseline in Heart Rate (HR)

  Up to Day 78

Study Arms (2)

REGN5381

EXPERIMENTAL

Single dose REGN5381 administered via IV infusion

Drug: REGN5381

Placebo

OTHER

Placebo matching single dose REGN 5381 administered via IV infusion

Other: Placebo

Interventions

REGN5381 DRUG

Single dose REGN5381 administered via IV infusion

REGN5381

Placebo OTHER

Placebo matching single dose REGN 5381 administered via IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of cardiovascular disease as defined in the protocol
• Protocol-defined risk factors for cardiovascular disease
• History of unexplained syncope, autonomic dysfunction, or neurologic disease.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Ghent University

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, B-3000, Belgium

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

BE (2)