A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants

April 12, 2024 updated by: Regeneron Pharmaceuticals

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects

The primary objective of the study is to:

• Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.

The secondary objectives of the study are to:

  • Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381
  • Evaluate the hemodynamic effects of single IV doses of REGN5381
  • Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo)
  • Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • Universitair Ziekenhuis Leuven Gasthuisberg Campus
  • Germany
      • Berlin, Germany, 10117
        • Charite Research Organisation GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  1. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
  2. Normal or mildly elevated blood pressure as defined in the protocol.

Key Exclusion Criteria:

  1. History of unexplained syncope or autonomic dysfunction.
  2. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
  3. Protocol-defined risk factors for cardiovascular disease.

Note: Other protocol defined inclusion / exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A
Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration.
Drug: REGN9035
Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.
Other: Placebo
Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22.
Experimental: Part B
Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion
Drug: REGN9035
Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.
Other: Placebo
Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22.
Drug: REGN5381
Part B: Selected doses administered by IV infusion on day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 162
Up to Day 162

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean systolic blood pressure (SBP) obtained after study drug administration
Time Frame: Up to Day 3
Up to 24 hours after study drug administration.
Up to Day 3
Mean diastolic blood pressure (DBP) obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Mean arterial pressure (MAP) obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Mean pulse pressure (PP) obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Mean pulse rate (PR) obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Mean stroke volume (SV) obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration
Time Frame: Up to Day 3
Up to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration.
Time Frame: Baseline to Day 3
Baseline to Day 3
Time to return to within 10% of baseline (pre-REGN5381) SBP
Time Frame: Up to approximately Day 162
Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) DBP
Time Frame: Up to approximately Day 162
Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) MAP
Time Frame: Up to approximately Day 162
Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) PP
Time Frame: Up to approximately Day 162
Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) PR
Time Frame: Up to approximately Day 162
Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) SV
Time Frame: Up to approximately Day 162
Up to approximately Day 162
SBP
Time Frame: Through Day 36
Through Day 36
DBP
Time Frame: Through Day 36
Through Day 36
MAP
Time Frame: Through Day 36
Through Day 36
PP
Time Frame: Through Day 36
Through Day 36
PR
Time Frame: Through Day 36
Through Day 36
Absolute change from baseline in SBP
Time Frame: Through Day 36
Through Day 36
Absolute change from baseline in DBP
Time Frame: Through Day 36
Through Day 36
Absolute change from baseline in MAP
Time Frame: Through Day 36
Through Day 36
Absolute change from baseline in PP
Time Frame: Through Day 36
Through Day 36
Absolute change from baseline in PR
Time Frame: Through Day 36
Through Day 36
Percent change from baseline in SBP
Time Frame: Through Day 36
Through Day 36
Percent change from baseline in DBP
Time Frame: Through Day 36
Through Day 36
Percent change from baseline in MAP
Time Frame: Through Day 36
Through Day 36
Percent change from baseline in PP
Time Frame: Through Day 36
Through Day 36
Percent change from baseline in PR
Time Frame: Through Day 36
Through Day 36
Concentrations of total REGN9035
Time Frame: Up to Day 162
Up to Day 162
Concentrations of total REGN5381 over time
Time Frame: Up to Day 162
Up to Day 162
Concentrations of total REGN9035 and/or total REGN5381
Time Frame: Up to Day 162
Up to Day 162

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R9035-HV-2125
  • 2021-005174-26 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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