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A phase 1, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of PRAX-628 in healthy participants

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Trial Profile

A phase 1, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of PRAX-628 in healthy participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Vormatrigine (Primary)
  • Indications Epilepsy; Partial epilepsies
  • Focus Adverse reactions; First in man
  • Acronyms PRAX-628-101
  • Sponsors Praxis Precision Medicines

Most Recent Events

  • 24 Mar 2025 According to a Praxis Precision Medicines media release, data from this study will be presented in a Poster presentation (P4-006) on Wednesday, April 9, 8:00 AM - 9:00 AM PT at the American Academy of Neurology (AAN) 2025 Annual Meeting taking place from April 5 to 9, 2025 in San Diego, California.
  • 08 Jan 2024 According to a Praxis Precision Medicines media release, data from this study demonstrated that PRAX-628 can be safely dosed in healthy subjects to greater than 15 times the predicted human equivalent of the rodent MES EC50.
  • 31 Aug 2023 According to a Praxis Precision Medicines media release, data from this trial will be presented at the upcoming 35th International Epilepsy Congress (IEC) 2023.

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