A study on the safety, tolerability, and effects of GM-2505

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.

Topic Depression Healthy Subjects
Country Netherlands
Visit trial
Status Completed
Results Published No
Start date 30 August 2022
End date 01 July 2023
Phase Not Applicable
Design Blinded
Type Interventional
Generation Second
Participants 48
Sex All
Age 18- 55
Therapy Yes

Trial Details

This study investigates the safety, pharmacokinetics, and pharmacodynamics of GM-2505, a new psychedelic drug, through single ascending intravenous doses administered to healthy volunteers. Psychedelics like GM-2505, which increase serotonin levels in the brain, have shown potential in treating psychiatric disorders when combined with psychotherapy. However, GM-2505 has not yet been tested in humans, and this study aims to characterise its effects and safety profile. The research, conducted at the Centre for Human Drug Research in the Netherlands and funded by Gilgamesh Pharmaceuticals, involves up to six cohorts of eight participants each, with potential side effects including hypertension, nausea, and anxiety. The study ran from August 2022 to July 2023.

NCT Number ISRCTN64428072

Sponsors & Collaborators

Gilgamesh
Gilgamesh Pharmaceuticals is a clinical-stage biotechnology company focused on developing innovative treatments for mental health disorders.

Data attribution

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