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Completed

NCT Number: NCT04506645

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ghent University, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

NOTE: Additional Inclusion / Exclusion criteria apply

Treatment and study plan

REGN5381

Drug

Single dose REGN5381 administered via IV infusion

Placebo

Other

Placebo matching single dose REGN 5381 administered via IV infusion

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to Day 78

Secondary outcomes

  1. Change from baseline in Systolic Blood Pressure (SBP)

    Time frame: Up to Day 78

  2. Change from baseline in Diastolic Blood Pressure (DBP)

    Time frame: Up to Day 78

  3. Change from baseline in Mean Arterial Pressure (MAP)

    Time frame: Baseline to Day 4

  4. Change from baseline in Pulse Pressure (PP)

    Time frame: Baseline to Day 4

  5. Change from baseline in Heart Rate (HR)

    Time frame: Up to Day 78

  6. Change from baseline in Stroke Volume (SV)

    Time frame: Baseline to Day 4

  7. Maximum change from baseline in SBP across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  8. Maximum change from baseline in DBP across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  9. Maximum change from baseline in MAP across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  10. Maximum change from baseline in PP across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  11. Maximum change from baseline in HR across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  12. Maximum change from baseline in SV across the first 24 hours postdose

    Time frame: Baseline to Day 2 (24-hours post dose)

  13. Change from baseline in the 24-hour mean SBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Time frame: Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose

    Baseline 24-hour mean SBP is measured from 0 to 24 hours pre-dose

  14. Change from baseline in the 24-hour mean DBP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Baseline 24-hour mean DBP is measured from 0 to 24 hours pre-dose

  15. Change from baseline in the 24-hour mean MAP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Baseline 24-hour mean MAP is measured from 0 to 24 hours pre-dose

  16. Change from baseline in the 24-hour mean PP measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Baseline 24-hour mean PP is measured from 0 to 24 hours pre-dose

  17. Change from baseline in the 24-hour mean HR measured from 0 to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Time frame: Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose

    Baseline 24-hour mean HR is measured from 0 to 24 hours pre-dose

  18. Concentrations of REGN5381 over time

    Time frame: Up to Day 78

  19. Number of subjects who develop anti-drug antibodies (ADA) and titers

    Time frame: Up to Day 78

  20. Percentage of subjects who develop anti-drug antibodies (ADA) and titers

    Time frame: Up to Day 78

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Humans

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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