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

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

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

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