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VRC 609: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

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Trial Profile

VRC 609: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs GSK 3810109 (Primary) ; GSK 3810109 (Primary) ; Hyaluronidase
  • Indications HIV-1 infections
  • Focus Adverse reactions; First in man
  • Acronyms VRC 609

Most Recent Events

  • 22 Feb 2023 Results(n=10) assessing safety of N6LS with rHuPH20 in healthy adults presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
  • 04 Oct 2022 Status changed from recruiting to completed.
  • 12 Jan 2022 Planned End Date changed from 31 Dec 2021 to 31 Dec 2022.

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