BPL-003 - first doses in humans
Research type
Research Study
Full title
A double-blind, randomized, Phase 1, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of intranasal BPL-003 (5-Methoxy-N,N-dimethyltryptamine benzoate) in healthy subjects
IRAS ID
1004390
Contact name
Christopher Moore
Contact email
Sponsor organisation
Beckley Psytech Ltd
Eudract number
2021-006225-22
Clinicaltrials.gov Identifier
Research summary
Research Summary:
This is a study of 5-MEO-DMT (BPL-003; the study treatment) – a psychedelic substance that occurs naturally in some plants and animals. We’re testing 5-MEO-DMT as an experimental new drug for treatment-resistant depression (TRD). There are existing treatments for depression, but they don’t work well in all patients. About a third of patients (30–40%) have TRD, meaning their depression doesn’t respond to at least 2 commonly available treatments. We hope the study treatment will give patients with TRD more treatment options. We’ll give up to 56 healthy volunteers, aged 25–55 and who have never taken a psychedelic substance before, single doses of the study drug or placebo. This formulation of 5-MEO-DMT (the study treatment) has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We will give single doses of study treatment intranasally, to find out: its side effects, blood levels, and psychedelic effects, and if it affects people’s mood, feelings, and ability to read facial expressions. We’ll also study how genes (pieces of DNA) affect the way the body responds to or handles the study treatment. Participants will take up to 2 weeks to finish the study. They’ll make up to 5 outpatient visits, up to 2 video calls, and stay on the ward for 3 days and 2 nights. Outpatient visits will include 2 psychedelic preparation visits with an experienced psychedelic researcher in the week before their dosing visit. Participants will attend a screening visit during the 7 weeks before the study. A pharmaceutical company (Beckley Psytech Ltd) is funding the study. The study will take place at 1 centre in London.Lay Summary of Results:
Lay Summary of Results of the BPL-003-103 Clinical Study
BPL-003-103: A two-part, Phase 1, single ascending dose study to evaluate the safety, tolerability and pharmacokinetic profile of intranasal BPL-003 in healthy subjects.
We would like to thank everyone who participated in this study. This document is a summary of the study. It is written for a general audience. Researchers look at the results of many studies to understand which drugs work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary only shows the results from this one study. Other studies evaluating the same drug may find different results.
Introduction This clinical study investigated the drug BPL-003, a formulation of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), to assess its safety, tolerability, and pharmacokinetic profile (how the drug is absorbed, distributed, metabolised, and eliminated by the body) when administered as a nasal spray. The insights gained from this study are intended to inform future research regarding the treatment-related potential of this drug, particularly in the context of mental health treatment.
Why was this study done? 5-MeO-DMT is a psychedelic compound that has garnered interest for its potential health benefits. The primary aim of this study was to identify any side effects associated with BPL-003 and to better understand how the drug interacts with the body. This study did not test if the drug helped to improve health.
Study Details
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Duration: The study was conducted between February 14, 2022, and January 19, 2024.
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Location: The research took place at HMR (Hammersmith Medicines Research) in London, UK.
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Participants: A total of 62 healthy volunteers, aged 25 to 55, participated in the study. Participants were selected based on strict health criteria to ensure they had no history of psychiatric or mental health-related disorders or prior psychedelic use.
Researchers did medical tests on participants before and after they took the drug.
This study is called a single ascending dose study. In this type of study one dose strength is given to some of the participants and the study results collected and analysed. If it is assessed safe to do so the next group of participants receive a higher dose.
Part A of this study was a “randomised” study which means that participants were put into the placebo (i.e. a dummy medicine that looks the same as the study treatment but has no active ingredient) or BPL-003 group by chance. Part A was also “double-blinded”. This means that neither participants nor doctors knew who was given BPL-003 and who was given placebo.
Part B of the study was open-label (everyone knew they were receiving the active drug), and evaluated two different formulations of BPL-003 as well as the effect of splitting a dose into 2 nasal spays.
All participants were required to provide written consent to the study in order to participate. They visited the study clinic once before the study started to make sure they met the criteria required to participate in the study. Participants attended 2 meetings with the psychedelic monitor, a type of therapist, before the dosing. The psychedelic monitor explained what to expect from a psychedelic experience and discussed ways to navigate the experience. After receiving the dose on the treatment day participants remained at the clinic until the next day. Researchers took samples of blood from participants to measure the amount of 5-MeO-DMT in their blood. The psychedelic monitor remained with the participant after the dosing to provide psychological support if needed. The participants attended a meeting 2 days after dosing to discuss the experience with the psychedelic monitor. The final meeting with the research team was 7 days after the treatment day.
What were the side effects?
Like all medicines, the study drug can cause side effects, although not everybody gets them. Side effects are unwanted events thought to be related to the treatments in the study. The most common side effects occurring in more than 10% of the participants who received either placebo or BPL-003 were:
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Nasal discomfort: Placebo = 0 of 13 (0%) / BPL-003 = 17 of 49 (35%)
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Nausea: Placebo = 0 of 13 (0%) / BPL-003 = 12 of 49 (24%)
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Vomiting: Placebo = 0 of 13 (0%) / BPL-003 = 9 of 49 (18%)
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Headache: Placebo = 0 of 13 (0%) / BPL-003 = 8 of 49 (16%)
What were the other study results? The study was completed as planned, yielding several important findings:
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Pharmacokinetics: 5-MeO-DMT was rapidly absorbed into the bloodstream, reaching peak concentrations (the highest amount of drug in the blood) within 4 to 20 minutes after administration. The drug was cleared from the system within a few hours, with all detectable levels of 5-MeO-DMT gone after less than 4 hours.
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Psychedelic Effects: As expected with this type of medication, participants reported a range of subjective experiences (personal perceptions and feelings) which were more common with increasing dose levels, including:
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A sense of ego dissolution (a loss of the sense of self).
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A "mystical experience," characterized by feelings of profound connection and transcendence.
Most participants indicated they would be willing to participate in future studies involving similar or higher doses, reflecting a positive overall experience.
Conclusion The results of this study provide valuable information regarding the safety and pharmacokinetic behavior of 5-MEO-DMT, administered either as a single nasal spray or two sprays. The findings suggest that the drug is generally well-tolerated, with manageable side effects and rapid clearance from the body. The results from this study will help in the planning of future clinical studies with this and related drugs.
Further information
If you have questions about the results of your study, please speak with the doctor or staff at the study site.
For more details on the study protocol, please visit:
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www.clinicaltrials.gov - Use the study identifier NCT05347849
The identification numbers of this clinical study are
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Protocol Number: BPL-003-103
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EudraCT Number: 2021-006225-22REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0834
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion