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A Phase 1/1b Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PAS-004, a MAPK/ERK Kinase 1/2 (MEK 1/2) Inhibitor, in Adult Participants With Neurofibromatosis Type 1 (NF1) With Symptomatic and Inoperable, Incompletely Resected, or Recurrent Plexiform Neurofibromas

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Trial Profile

A Phase 1/1b Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PAS-004, a MAPK/ERK Kinase 1/2 (MEK 1/2) Inhibitor, in Adult Participants With Neurofibromatosis Type 1 (NF1) With Symptomatic and Inoperable, Incompletely Resected, or Recurrent Plexiform Neurofibromas

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs PAS 004 (Primary)
  • Indications Neurofibromatosis 1
  • Focus Adverse reactions
  • Sponsors Pasithea Therapeutics

Most Recent Events

  • 16 May 2025 New trial record
  • 14 May 2025 According to Pasithea Therapeutics Corp media release, The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in Q2 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months. asithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for this trial.
  • 14 May 2025 Status changed from not yet recruiting to recruiting.

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