The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
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Safety and tolerability: incidence of treatment emergent adverse events
Timeframe: Up to 7 days
Safety and tolerability: local tolerance (injection site reactions)
Timeframe: Up to discharge on dosing day
Safety and tolerability: Clinically significant changes from baseline in ECG, vital signs and safety laboratory assessments
Timeframe: Up to 7 days
Safety and tolerability: Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0
Timeframe: Up to discharge on dosing day
Safety and tolerability: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Timeframe: Up to 7 days
Safety and tolerability: Assessment of subject-discharge readiness at discharge on Day 0
Timeframe: Up to discharge on dosing day
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization based on the Columbia Classification Algorithm of Suicide Assessment (C-CASA).
Timeframe: Up to 7 days
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Timeframe: Up to 7 days
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT
Timeframe: Up to 6 hours