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A phase 1 proof of concept data in sleep-deprived healthy volunteers

Trial Profile

A phase 1 proof of concept data in sleep-deprived healthy volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs ORX 750 (Primary)
  • Indications Narcolepsy
  • Focus Adverse reactions; First in man; Proof of concept
  • Most Recent Events

    • 06 Mar 2025 According to a Centessa Pharmaceuticals media release, data of this trial will be presented in a poster session at the American Academy of Neurology (AAN) 2025 Annual Meeting being held April 5-9, 2025, in San Diego, CA.
    • 12 Nov 2024 According to a Centessa Pharmaceuticals media release, Presentation of Phase 1 data planned for medical congress in Q2 2025.
    • 10 Sep 2024 According to a Centessa Pharmaceuticals media release, as of September 10, 2024, the study has completed three SAD cohorts of healthy volunteers (27 active, 9 placebo) with doses of 1.0 mg, 2.0 mg, and 2.5 mg, and has advanced through two cohorts within the cross-over assessment of acutely sleep-deprived healthy volunteers with doses of 1.0 mg (n=8) and 2.5 mg (n=8), administered as a single oral dose. Dosing in the MAD portion of the study is also ongoing.

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