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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs REGN 5381 (Primary) ; REGN 9035 (Primary)
  • Indications Heart failure; Hypertension
  • Focus Adverse reactions
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 12 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 08 Dec 2023 Planned End Date changed from 10 Jul 2024 to 29 Apr 2024.
    • 08 Dec 2023 Planned primary completion date changed from 10 Jul 2024 to 29 Apr 2024.

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