Status:
COMPLETED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 secon...
Eligibility Criteria
Inclusion
- 1\. Normal or mildly elevated blood pressure as defined in the protocol
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04506645
Start Date
September 1 2020
End Date
December 14 2022
Last Update
December 20 2022
Active Locations (2)
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1
Ghent University
Ghent, Belgium, 9000
2
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Belgium, B-3000