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.”

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

Data attribution

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