atai Life Sciences announced the publication of the Phase 1 results of BPL-003, Beckley Psytech’s novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT, in The Journal of Psychopharmacology. The double-blind, placebo-controlled, single ascending dose Phase 1 study explored the safety, tolerability, pharmacokinetics and pharmacodynamics of BPL-003 in combination with psychological support in 44 psychedelic-naive healthy volunteers. The paper shows that BPL-003 was safe and well-tolerated with no serious or severe adverse events reported. BPL-003 was rapidly absorbed and eliminated, with 5-MeO-DMT systemic exposure increasing approximately dose-proportionally. There was a reliable onset of subjective psychedelic effects within minutes, which resolved in less than two hours. The intensity of the subjective psychedelic experience was shown to correlate with exposure to the compound. The PD endpoint scores of the Mystical Experience Questionnaire and Ego Dissolution Inventory increased with an increase in the BPL-003 dose. Sixty percent of participants had a ‘complete mystical experience,’ which is defined as reaching or exceeding a score of three on all four subdomains of the MEQ-30 scale, at 10 mg and 12 mg doses of BPL-003.
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