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drugset / Trial / NCT05347849

Single Ascending Dose Study With BPL-003 in Healthy Subjects

NCT05347849 ↗

Phase 1 Completed 62 enrolled Beckley Psytech Limited

RandomizedSequentialQuadruple-blindTreatment

Summary

The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects

Timeline

Start: 2022-02-14
Primary completion: 2024-01-19
Completion: 2024-01-19

Publications

Rucker JJ, Roberts C, Seynaeve M, Young AH, Suttle B, Yamamoto T, Ermakova AO, Dunbar F, Wiegand F. Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants. J Psychopharmacol. 2024 Aug;38(8):712-723. doi: 10.1177/02698811241246857. Epub 2024 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mebufotenin	Small molecule	10 mg	Intranasal
Subject	Mebufotenin	Small molecule	12 mg	Intranasal

Indications

No indication recorded.