Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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: * Evaluat...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05291546
Start Date
April 13 2022
End Date
April 2 2024
Last Update
April 15 2024
Active Locations (2)
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1
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, Belgium, B-3000
2
Charite Research Organisation GmbH
Berlin, Germany, 10117