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Clinical Trials/NCT04506645
NCT04506645CompletedPhase 1

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

Regeneron Pharmaceuticals2 sites in 1 country90 target enrollmentStarted: September 1, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Incidence of Treatment-Emergent Adverse Events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

REGN5381

Experimental

Single dose REGN5381 administered via IV infusion

Intervention: REGN5381 (Drug)

Placebo

Other

Placebo matching single dose REGN 5381 administered via IV infusion

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time Frame: Up to Day 78

Secondary Outcomes

  • Change from baseline in Pulse Pressure (PP)(Baseline to Day 4)
  • Maximum change from baseline in MAP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • Maximum change from baseline in HR across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • Maximum change from baseline in SV across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • 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(Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose)
  • 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(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
  • 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)
  • Maximum change from baseline in PP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • Change from baseline in Heart Rate (HR)(Up to Day 78)
  • Maximum change from baseline in SBP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • Change from baseline in Stroke Volume (SV)(Baseline to Day 4)
  • Maximum change from baseline in DBP across the first 24 hours postdose(Baseline to Day 2 (24-hours post dose))
  • 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(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
  • 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(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
  • 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(Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose)
  • Concentrations of REGN5381 over time(Up to Day 78)
  • Number of subjects who develop anti-drug antibodies (ADA) and titers(Up to Day 78)
  • Percentage of subjects who develop anti-drug antibodies (ADA) and titers(Up to Day 78)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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