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
Chance of happening
100%
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.NCT Number NCT05347849
Sponsors & Collaborators
Beckley PsytechBeckley 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 participantsThis 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.