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A Phase 1, Open-label, Parallel , Single dose, Multicohort study in healthy participants Analyzing Impact of Subcutaneous Administration Sites on the Clinical Pharmacokinetics of Lenacapavir

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Trial Profile

A Phase 1, Open-label, Parallel , Single dose, Multicohort study in healthy participants Analyzing Impact of Subcutaneous Administration Sites on the Clinical Pharmacokinetics of Lenacapavir

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 08 Feb 2024

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At a glance

  • Drugs Lenacapavir (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics

Most Recent Events

  • 16 May 2022 According to a Gilead Sciences media release, Following the decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP.
  • 16 May 2022 According to a Gilead Sciences media release, the USA Food and Drug Administration (FDA) has lifted the clinical hold placed on the Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).
  • 16 May 2022 Status changed from suspended to planning, according to a Gilead Sciences media release.

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