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

NCT05291546 | Completed Phase 1

• 2 other identifiers: R9035-HV-21252021-005174-26
• Study Type: interventional
• Target: 93
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Mild Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

  Up to Day 162

Secondary Outcomes (90)

• Mean systolic blood pressure (SBP) obtained after study drug administration

  Up to Day 3

• Mean diastolic blood pressure (DBP) obtained after study drug administration

  Up to Day 3

• Mean arterial pressure (MAP) obtained after study drug administration

  Up to Day 3

• Mean pulse pressure (PP) obtained after study drug administration

  Up to Day 3

• Mean pulse rate (PR) obtained after study drug administration

  Up to Day 3

Study Arms (2)

Part A

EXPERIMENTAL

Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration.

Drug: REGN9035; Other: Placebo

Part B

EXPERIMENTAL

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; Drug: REGN5381; Other: Placebo

Interventions

REGN9035 DRUG

Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.

Part A; Part B

REGN5381 DRUG

Part B: Selected doses administered by IV infusion on day 1.

Part B

Placebo OTHER

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.

Part A; Part B

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, B-3000, Belgium

Location

Charite Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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: February 28, 2022
• First Posted: March 22, 2022
• Study Start: April 13, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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

Locations

DE (1); BE (1)