A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- 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.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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.
Note: Other protocol defined inclusion / exclusion criteria apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Healthy Volunteers
Age (in years)
18 - 55
Phase
Phase 1
Participants needed
107
Est. Completion Date
Jul 10, 2024
Treatment type
Interventional
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov identifier
NCT05291546
Study number
R9035-HV-2125
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