Clinical TrialHealthy Volunteers5-MeO-DMTPlaceboCompleted

Single Ascending Dose Study With BPL-003 in Healthy Subjects

Randomised Phase I single ascending-dose intranasal study (n=62) evaluating safety, tolerability and pharmacokinetics of BPL-003 (5‑MeO‑DMT) in healthy adults.

Target Enrollment
62 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

A randomised, sequential single ascending-dose study in healthy adults testing single intranasal doses of BPL-003 (5‑MeO‑DMT) versus placebo.

Primary outcomes are safety and tolerability; secondary outcomes include pharmacokinetic profiling. Masking noted as quadruple (Part A only) in the registry.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

BPL-003

experimental

Single intranasal dose of BPL-003 (5‑MeO‑DMT).

Interventions

  • 5-MeO-DMT
    via Other• single dose• 1 doses total

    Intranasal administration; dose not specified in registry fragment.

Placebo

inactive

Single intranasal placebo dose.

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Intranasal placebo.

Participants

Ages
25 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Medically healthy based on medical records and study specific assessments

Exclusion Criteria

  • Exclusion Criteria:
  • Presence or history of severe adverse reaction to any drug or drug excipient

Primary Results(1 publication)

Participants

N = 10Mean age: 44.5 across armsA. et al. 2025 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
BPL-003experimental1046(460.0%)—0(0.0%)—
Placeboinactive0————

* The paper reports a total of 46 adverse events recorded; however, these are described as 'events' rather than 'participants with events'. Given the small sample size (n=10) and the text stating 'All ten participants completed the psilocybin therapy course', it is likely that the 46 events were distributed among the 10 participants. Since the prompt asks for participants with >=1 TEAE and the text does not explicitly provide the number of unique participants experiencing events, but confirms all 10 completed the course and events were mild/transient, I am providing the event count if interpreted as participant-level, but the text specifically says 'A total of 46 adverse events were recorded'. Re-evaluating: The text says 'All ten participants completed the psilocybin therapy course' and 'A total of 46 adverse events were recorded'. It does not specify how many participants had at least one. However, in clinical reporting, if 46 events occurred in 10 people, it is highly probable all 10 had at least one. I will set teaeAny_n to null as the exact number of unique participants is not explicitly stated, but note the total event count.

* This was an open-label, single-group study; no placebo arm was present in the reported data.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment62 participants
  • Timeline
    Start: 2022-02-14
    End: 2022-04-30
  • Compounds
    5-MeO-DMTPlacebo
  • Topic
    Healthy Volunteers

Locations

Hammersmith Medicines Research — London, United Kingdom

Related Publications

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

Published
Authors
Rucker, J., Roberts, C. A., Seynaeve, M., Young, A. H., Suttle, B., Yamamoto, T., Ermakova, A. O., Dunbar, F., Wiegand, F.

Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study

Published
Authors
Fink-Jensen, A., Jensen, M. E., Stenbæk, D. S., Messell, C. D., Poulsen, E. D., Varga, T. V., Fisher, P. M., Nielsen, M. K. K., Johansen, S. S., Volkow, N. D., Knudsen, G. M.

Your Library

Single Ascending Dose Study With BPL-003 in... — Clinical Trial Details | Blossom