A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults

The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults.

The study is looking at several other research questions, including:

• What side effects may happen from taking the study drug
• How much study drug is in your blood at different times
• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN7544; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m^2
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug, as defined in the protocol
3. Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
4. Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
2. History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP <90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
3. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
4. Was hospitalized (ie, >24 hours) for any reason within 30 days of screening
5. Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening

NOTE: Other protocol defined inclusion / exclusion criteria apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Dose Level 1; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 2; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 3; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 4; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 5; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 6; Randomized 6:2 for single ascending IV dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 1; Randomized 6:2 for single ascending SC dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 2; Randomized 6:2 for single ascending SC dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 3; Randomized 6:2 for single ascending SC dose	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: Optional Cohort 1; Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol
Experimental: Optional Cohort 2; Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level	Drug: REGN7544; Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration; Drug: Matching Placebo; Solution for single ascending IV or SC administration per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)	Through approximately day 162
Severity of TEAEs	Through approximately day 162

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in Systolic Blood Pressure (SBP)	Through day 6
Changes from baseline in Diastolic Blood Pressure (DBP)	Through day 6
Changes from baseline in Mean Arterial Pressure (MAP)	Through day 6
Changes from baseline in Pulse Pressure (PP)	Through day 6
Concentrations of REGN7544 in serum over time	Through approximately day 162
Incidence of treatment-emergent Anti-Drug Antibody (ADA)	Through approximately day 162
Titer of ADA	Through approximately day 162

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Hypotension and/or hypovolemia
• Other Study ID Numbers: R7544-HV-22109

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 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