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.

Ask Blossom about this trial
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

Study Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

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

Paywallindividual

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

In this double-blind, placebo-controlled Phase 1 trial, intranasal BPL-003 (5‑MeO‑DMT benzoate) was well tolerated up to 12 mg and showed rapid absorption and elimination with dose‑proportional systemic exposure (Tmax ≈ 8–10 min; mean terminal half‑life <27 min) and negligible bufotenine formation. Pharmacodynamic effects scaled with plasma concentrations, producing profound, short‑lasting consciousness‑altering and mystical experiences—60% of participants had a complete mystical experience at 10–12 mg—supporting further clinical evaluation.

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

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

This 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.

Published
Journal
Journal of Psychopharmacology
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 Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans