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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506645
• Other study ID #: R5381-HV-1987
• Secondary ID: 2020-000940-75
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Normal or mildly elevated blood pressure as defined in the protocol

Exclusion Criteria:

1. History of cardiovascular disease as defined in the protocol

2. Protocol-defined risk factors for cardiovascular disease

3. History of unexplained syncope, autonomic dysfunction, or neurologic disease.

NOTE: Additional Inclusion / Exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• REGN5381
Single dose REGN5381 administered via IV infusion

Other:
• Placebo
Placebo matching single dose REGN 5381 administered via IV infusion

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	Universitair Ziekenhuis Leuven Gasthuisberg Campus	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events		Up to Day 78
Secondary	Change from baseline in Systolic Blood Pressure (SBP)		Up to Day 78
Secondary	Change from baseline in Diastolic Blood Pressure (DBP)		Up to Day 78
Secondary	Change from baseline in Mean Arterial Pressure (MAP)		Baseline to Day 4
Secondary	Change from baseline in Pulse Pressure (PP)		Baseline to Day 4
Secondary	Change from baseline in Heart Rate (HR)		Up to Day 78
Secondary	Change from baseline in Stroke Volume (SV)		Baseline to Day 4
Secondary	Maximum change from baseline in SBP across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	Maximum change from baseline in DBP across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	Maximum change from baseline in MAP across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	Maximum change from baseline in PP across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	Maximum change from baseline in HR across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	Maximum change from baseline in SV across the first 24 hours postdose		Baseline to Day 2 (24-hours post dose)
Secondary	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 24-hour mean SBP is measured from 0 to 24 hours pre-dose	Baseline to 24 hours postdose, 24 hours to 48 hours postdose, 48 hours to 72 hours postdose
Secondary	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 24-hour mean DBP is measured from 0 to 24 hours pre-dose	Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Secondary	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 24-hour mean MAP is measured from 0 to 24 hours pre-dose	Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Secondary	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 24-hour mean PP is measured from 0 to 24 hours pre-dose	Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Secondary	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 24-hour mean HR is measured from 0 to 24 hours pre-dose	Baseline to 24 hours, 24 to 48 hours, and 48 to 72 hours postdose
Secondary	Concentrations of REGN5381 over time		Up to Day 78
Secondary	Number of subjects who develop anti-drug antibodies (ADA) and titers		Up to Day 78
Secondary	Percentage of subjects who develop anti-drug antibodies (ADA) and titers		Up to Day 78