IM and IV SPL026 Drug Product in Healthy Participants (NCT05644093) | Clinical Trial Compass
CompletedPhase 1
IM and IV SPL026 Drug Product in Healthy Participants
United Kingdom14 participantsStarted 2023-01-03
Plain-language summary
The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy psychedelic-experienced female or male participants (psychedelic-experienced is defined as having at least 2 previous experiences, with breakthrough, of serotonergic psychedelic drugs, including but not limited to: DMT, ayahausca, LSD, LSA \[morning glory seeds\], DOI \[2,5-Dimethoxy-4- iodoamphetamine\], DOB \[dimethoxybromoamphetamine\], DOC \[2,5- Dimethoxy-4-chloroamphetamine\], 2CB \[2-(4-bromo-2,5- dimethoxyphenyl)ethanamine\], 2CE \[1-(2,5-Dimethoxy-4-ethylphenyl)-2- aminoethane\], mescaline, peyote, san pedro, ibogaine and psilocybin \[including mushroom species containing psilocybin\]).
. No psychedelic drug use within 6 weeks prior to dosing.
. Healthy female or male participants with little to no psychedelic experience (defined as having never taken serotonergic psychedelic drugs, or have only taken sub-breakthrough doses of serotonergic psychedelic drugs, in any form, \< 5 times, including but not limited to: DMT, ayahuasca, LSD, LSA, DOI, DOB, DOC, 2CB, 2CE, mescaline, peyote, san pedro, ibogaine and psilocybin \[including mushroom species containing psilocybin\]).
. No psychedelic drug use within 6 months prior to dosing.
. Aged 25-65 years.
. A body mass index (BMI; Quetelet index) in the range 18.0-33.9 kg/m2. Body Mass Index =
. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lab biochemistry [Safety & Tolerability]
Timeframe: Change from baseline at Day 1 post dose
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: Throughout the study until 14 days after dosing (Day 15 EOS)
3
Heart Rate [Vital Signs - Safety & Tolerability]
Timeframe: Change from baseline heart rate at Day 1 or Day 2 post dose
. Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
Exclusion criteria
. Current or previously diagnosed mental health disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
. First degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar and related disorders.
. Disposition judged by the investigator (or delegate) to be incompatible with establishment of rapport with therapy team and/or safe exposure to DMT.
. Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception (see section 11).
. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the participant.
. Presence of acute or chronic illness, condition or infection, or history of chronic illness or condition (including psychological and neurological \[eg seizure\] disorder) considered sufficient to invalidate the participant's participation in the trial or make it unnecessarily hazardous.
. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or any of the following cardiovascular conditions: arrhythmia, a clinically significant screening ECG abnormality or family history of long QT syndrome or sudden death, artificial heart valve, current or any history of hypertension, or any other significant current or history of cardiovascular condition, that may affect safety in the opinion of the investigator.
. History of serious suicide attempts (ie those that require hospitalisation); as assessed by the BSS.
8
Beck Scale for Suicidal Ideation (BSS) - [Safety & Tolerability]
Timeframe: Change from baseline at Day 15 post dose