Single ascending dose study with BPL-003 in healthy subjects
| ISRCTN | ISRCTN10271810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10271810 |
| EudraCT/CTIS number | 2021-006225-22 |
| IRAS number | 1004390 |
| ClinicalTrials.gov number | NCT05347849 |
| Secondary identifying numbers | CRO code: 21-013 |
- Submission date
- 24/01/2022
- Registration date
- 26/01/2022
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
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.
Who can participate?
Healthy volunteers, aged 25–55 years who have never taken a psychedelic substance before
What does the study involve?
We’ll give participants 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.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study will take place at 1 centre in London (HMR)
When is the study starting and how long is it expected to run for?
November 2021 to January 2024
Who is funding the study?
A pharmaceutical company (Beckley Psytech Ltd) is funding the study.
Who is the main contact?
medinfo@beckleypsytech.com
Contact information
Public
Beckley Psytech
Beckley Park
Oxford
OX3 9SY
United Kingdom
| medinfo@beckleypsytech.com |
Principal Investigator
Hammersmith Medicines Research (HMR)
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Study design | First-in-man safety, pharmacokinetics and pharmacodynamics trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | A two-part 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 |
| Study acronym | BPL-003-103 |
| Study hypothesis | The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects. |
| Ethics approval(s) | 1. Approved 20/01/2022, London - Brent Research Ethics Committee (80 London Road, Skipton House, London, SE1 6LH, UK; +44 (0)20 7104 8128, 020 7104 8137; brent.rec@hra.nhs.uk), REC ref: 21/LO/0834 2. Approved 21/01/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 53791/0003/001-0001 The HRA has approved the deferral of the publication of trial details on 14/01/2022 |
| Condition | The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects |
| Intervention | Drug/ BPL-003 arm: BPL-003 - A single dose of BPL-003 will be administered intranasally. Placebo Comparator arm: Placebo - A single dose of placebo will be administered intranasally. Allocation: Randomized Interventional Model: Sequential Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Part A only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacokinetic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | BPL-003 (5-Methoxy-N,N-dimethyltryptamine Benzoate) |
| Primary outcome measure | Percentage of subjects with treatment emergent AEs (TEAES) [Time Frame: From screening through to the follow up visit, up to 65 days]. |
| Secondary outcome measures | 1. Peak plasma concentration (Cmax) [Time Frame: Day 1 (dosing day) and Day 2] 2. Time to reach Cmax (tmax) [Time Frame: Day 1 (dosing day) and Day 2] 3. Area under the plasma concentration- time curve [Time Frame: Day 1 (dosing day) and Day 2] |
| Overall study start date | 01/11/2021 |
| Overall study end date | 19/01/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 62 |
| Participant inclusion criteria | Medically healthy based on medical records and study specific assessments. |
| Participant exclusion criteria | Presence or history of severe adverse reaction to any drug or drug excipient. |
| Recruitment start date | 02/02/2022 |
| Recruitment end date | 22/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Park Royal
London
NW10 7EW
United Kingdom
Sponsor information
Industry
Beckley Park
Oxford
OX3 9SY
England
United Kingdom
| medinfo@beckleypsytech.com | |
| Website | https://www.beckleypsytech.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 14/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication of some trial details is deferred because of the high commercial sensitivity of this phase 1 study and the negligible benefit to the public of Phase I information. The sponsor does plan to report and disseminate the results of the study in the following ways: Internal Report, Conference Presentation, Publication on website and Submission to Regulatory Authorities. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to high commercial sensitivity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 14/04/2024 | 03/03/2025 | Yes | No |
Editorial Notes
03/03/2025: Publication reference added.
31/01/2025: The information for which publication was previously deferred has been added to the following fields:
1. The public title
2. The scientific title
3. Study hypothesis
4. Condition
5. Interventions
6. Drug name(s)
7. Primary outcome measure
8. Secondary outcome measures
9. Participant inclusion criteria
10. Participant exclusion criteria
11. Plain English summary
12. The recruitment end date was changed from 22/07/2022 to 22/12/2023.
13. The overall end date was changed from 22/07/2022 to 19/01/2024.
11/02/2022: The recruitment start date has been changed from 01/02/2022 to 02/02/2022.
26/01/2022: Trial's existence confirmed by the London - Brent Research Ethics Committee.
