This adaptive, randomised, double-blind, placebo-controlled trial (n=48) evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous doses of GM-2505 (second-gen, shorter duration, 5-HT2A agonist) in healthy volunteers.
The trial, conducted at the Centre for Human Drug Research in the Netherlands, aimed to characterise the effects of GM-2505, a novel psychedelic, by administering escalating doses intravenously. The study included up to six cohorts, each receiving a single dose of GM-2505, with sentinel dosing in the initial two participants of each cohort. It sought to measure various safety parameters, including adverse events and vital signs, as well as PK and PD metrics such as drug absorption and subjective effects.
Funded by Gilgamesh Pharmaceuticals, the study ran from August 2022 to July 2023 and was designed to expand knowledge about GM-2505’s effects and safety profile. The findings will contribute to the understanding of this investigational drug’s potential for future clinical applications.
Trial Details
Trial Number
Sponsors & Collaborators
GilgameshGilgamesh Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative treatments for mental health disorders.
Papers
A novel psychedelic 5-HT2A receptor agonist GM-2505: The pharmacokinetic, safety, and pharmacodynamic profile from a randomized trial healthy volunteerThis Phase I single-ascending dose, randomised, placebo-controlled, double-blind study (n=48) found that GM-2505, a novel 5-HT2A receptor agonist, demonstrated an acceptable safety profile with mild transient adverse events at intravenous doses up to 20 mg, a half-life of 40-50 minutes, and dose-dependent effects on neuroendocrine hormones, neuropsychological measures, and resting-state electroencephalography similar to other 5-HT2A receptor agonists but with a duration of effects shorter than psilocybin and longer than DMT.