CompletedPhase 1

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

Belgium90 participantsStarted 2020-09-01

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: Up to Day 78

Trial details

NCT IDNCT04506645

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-14

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