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An adaptive, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD) of GM-2505 in healthy volunteers

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Trial Profile

An adaptive, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate safety, pharmacokinetics (PK) and pharmacodynamics (PD) of GM-2505 in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2024

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At a glance

  • Drugs GM 2505 (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; First in man
  • Sponsors Gilgamesh Pharmaceuticals

    • Most Recent Events

    • 30 Nov 2023 According to a Gilgamesh Pharmaceuticals media release, Additional details will be presented at the American College of Neuropsychopharmacology (ACNP) meeting in December.
    • 30 Nov 2023 Status changed to completed, according to a Gilgamesh Pharmaceuticals media release.
    • 30 Nov 2023 According to a Gilgamesh Pharmaceuticals media release, successful completion of its Phase 1 Single Ascending Dose (SAD) trial of GM-2505. In the this Phase 1 study, a full range of GM-2505 doses have been tested with the highest doses of 15 and 20 mg manifesting a full psychedelic effect with minimal effects below 10 mg.

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