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

CompletedResults publishedRegisteredISRCTN

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.

Details

Adaptive single-ascending-dose, randomized, double-blind, placebo-controlled study in healthy volunteers assessing safety and tolerability of IV GM-2505 with cohorts receiving escalating single doses.

Primary outcomes include adverse events, labs, ECGs, vitals and psychometric measures up to 24 hours post-dose; secondary outcomes include detailed PK (AUC, Cmax, t1/2) and PD batteries (NeuroCart, VAS, MEQ-30, pharmaco-EEG).

Topics:Healthy Volunteers

Registry

Registry linkISRCTN64428072