Single Ascending Dose Study With BPL-003 in Healthy Subjects

The study evaluated the safety, tolerability and PK profile of BPL-003 (5-MeO-DMT) in healthy subjects.

The preliminary results have been published by Beckley Psytech: “Initial results show a dose-proportional pharmacokinetic (PK) profile and good tolerability with no serious adverse events reported. BPL-003 demonstrated rapid onset of effect within minutes and a short duration of experience, with all consciousness-altering effects resolving within 90 minutes. With the robust data generated thus far from this Phase I study, Beckley Psytech is now preparing to initiate its MHRA-approved Phase IIa studies evaluating BPL-003 in Treatment Resistant Depression and Alcohol Use Disorder in Q4 2022.”

Topic Healthy Subjects
Compound 5-MeO-DMT
Country United Kingdom
Visit trial
Status Completed
Results Published No
Start date 14 February 2022
End date 30 April 2022
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 56
Sex All
Age 25- 55
Therapy No

Trial Details

The study will evaluate the safety, tolerability and PK profile of BPL-003 (5-MeO-DMT) in healthy subjects.

Trial Number NCT05347849

Sponsors & Collaborators

Beckley Psytech
Beckley Psytech is working on getting 5-MeO-DMT to market as the first of a variety of psychedelic medicines.

Papers

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
This double-blind, placebo-controlled study (n=44) examines the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BPL-003, a novel intranasal benzoate salt formulation of 5-MeO-DMT (up to 12mg), in healthy participants. BPL-003 was well tolerated, showing rapid absorption and elimination.

Single-Dose Psilocybin Therapy for Alcohol Use Disorder: Pharmacokinetics, Feasibility, Safety, and Efficacy in an Open-Label Study
This pre-print, open-label study (n=10) investigates the effects of single-dose psilocybin (25mg) therapy in adults with severe alcohol use disorder (AUD). It finds significant reductions in alcohol consumption, craving, and increases in self-efficacy over 12 weeks following treatment despite notable between-participant pharmacokinetic variations.

Data attribution

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