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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Page 1 of 1 (2 locations)

1

Universitair Ziekenhuis Leuven Gasthuisberg Campus

Leuven, Belgium, B-3000

2

Charite Research Organisation GmbH

Berlin, Germany, 10117