Major Depressive DisorderPhase 1NCT05644093
IM and IV SPL026 Drug Product in Healthy Participants
A Phase 1 study testing SPL026 IV and SPL026 IM in people with Major Depressive Disorder, run by Small Pharma Ltd at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SPL026 IV and SPL026 IM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2023to 5 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A only
- 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.
- Part B only
- 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.
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- Parts A and B
- 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.
- 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.
- Agree to follow the contraception requirements of the trial.
- Agree not to donate blood or blood products during the study and for up to 3 months after the (last) administration of the trial medication.
- Willing to refrain from psychedelic drug use (excluding the study drug) during the trial and until the follow up call.
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
- Willing to be contacted by email and video call, and have online access.
- Has veins deemed suitable for cannulation (IV infusion and/or blood sampling).
Who cannot join
- 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.
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- 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.
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to serotonergic psychedelic drugs.
- Use of a prescription medicine (except oral contraceptives or any hormone therapy), certain herbal supplements (eg St John's Wort, to be reviewed by trial physician), or over-the-counter medicine, during the 28 days before the first dose of trial medication. Use of acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (eg ibuprofen) are permitted up to 4 h before the first dose of trial medication.
- Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before (first) admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
- Presence or history of drug or alcohol abuse, or intake of more than 14 units of alcohol weekly.
- Daily cannabis use or cannabis dependence as defined by ICD10.
- Use of cannabis in the 24 h before each study visit.
- Evidence of drug abuse on urine testing (with the exception of cannabis).
- Unable to be nicotine free (refrain from smoking or nicotine-containing products) for 24 h before and until the morning after dosing.
- Blood pressure and pulse rate in the supine and standing position at the screening examination outside the ranges: blood pressure 80-150 mm Hg systolic; 30-100 mm Hg diastolic; pulse rate 40-100 beats/min. Borderline values (ie values that are within 5 mm Hg of the range for blood pressure or 5 beats/min of the range for pulse rate) will be repeated. Participants can be included if the repeat value is within range or still borderline but deemed not clinically significant by the investigator.
- QTcF value at screening greater than 450 msec (men) or 470 msec (women) on 12-lead ECG. Triplicate measurements will be made, and a mean QTcF value higher than 450 msec (men) or 470 msec (women) will lead to exclusion. A repeat (in triplicate) is allowed on one occasion for determination of eligibility.
- Possibility that the participant will not cooperate with the requirements of the protocol.
- Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
- Phobia of needles or blood.
- Objection by General Practitioner (GP) to participant entering trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Cross-over Study of IM and IV Doses of SPL026 in Healthy, Psychedelic-experienced Participants (Part A: IM and IV Doses) and Participants With Little to no Psychedelic Experience (Part B: IM Dose Only)
The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.
Read the detailed description
Part A: Crossover IM then IV dosing with SPL026 in psychedelic experienced, healthy volunteers.
PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.
- Conditions
- Major Depressive Disorder
- Being tested
- SPL026 IV, SPL026 IM
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPL026 IVDrug
Also called DMT
IV dosing
SPL026 IMDrug
Also called DMT
IM dosing
| Study group | Role | What they receive |
|---|---|---|
| Psychedelic Experienced IM then IV crossover | Experimental | Participants will be dosed with IM SPL026 then IV SPL026 2-3 weeks later. Receives: Drug: SPL026 IV; Drug: SPL026 IM |
| Psychedelic Naive IM dosing only | Experimental | Participants will be dosed with IM SPL026 one time. Receives: Drug: SPL026 IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lab biochemistry [Safety & Tolerability]
Values of potential clinical importance
Measured: Change from baseline at Day 1 post dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events (AEs)
Measured: Throughout the study until 14 days after dosing (Day 15 EOS)
Heart Rate [Vital Signs - Safety & Tolerability]
pulse rate will be measured in bpm
Measured: Change from baseline heart rate at Day 1 or Day 2 post dose
Blood Pressure [Vital Signs - Safety & Tolerability]
arterial blood pressure
Measured: Change from baseline blood pressure at Day 1 or Day 2 post dose
Temperature [Vital Signs - Safety & Tolerability]
tympanic temperature
Measured: Change from baseline temperature at Day 1 or Day 2 post dose
12-lead ECG [Safety & Tolerability]
QTcX intervals
Measured: Change from baseline ECG at Day 1 or Day 2 post dose
Physical Exam [Safety & Tolerability]
Full physical exam screening and a brief symptom guided exam at Day -1 and Day 1
Measured: Change from baseline at Day 1 post dose
Beck Scale for Suicidal Ideation (BSS) - [Safety & Tolerability]
The Beck Suicidal Ideation scale to monitor suicidal ideation
Measured: Change from baseline at Day 15 post dose
Secondary outcomes (3)
Evaluation of plasma levels of DMT
Pharmacokinetic parameter calculation
Measured: Day 1
Mystical Experience Questionnaire (MEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]
Compare MEQ between different routes of administration (IV \& IM)
Measured: Day 1 (dosing day)
Challenging Experience Questionnaire (CEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]
Compare CEQ between different routes of administration (IV \& IM)
Measured: Day 1 (dosing day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start3 Jan 2023
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Small Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, MD, Principal investigator, HMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644093
- Sponsor's protocol ID
- CT026_003
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for this yet.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Cross-over Study of IM and IV Doses of SPL026 in Healthy, Psychedelic-experienced Participants (Part A: IM and IV Doses) and Participants With Little to no Psychedelic Experience (Part B: IM Dose Only)
- ClinicalTrials.gov ID
- NCT05644093
- Acronym / sponsor ID
- CT026_003
- Conditions
- Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Small Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.
Detailed description
Part A: Crossover IM then IV dosing with SPL026 in psychedelic experienced, healthy volunteers.
PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychedelic Experienced IM then IV crossover | Experimental | Drug: SPL026 IV, Drug: SPL026 IMParticipants will be dosed with IM SPL026 then IV SPL026 2-3 weeks later. |
| Psychedelic Naive IM dosing only | Experimental | Drug: SPL026 IMParticipants will be dosed with IM SPL026 one time. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Part A only
- 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.
- Part B only
- 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]).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPL026 IVAlso: DMTIV dosing | Drug | Psychedelic Experienced IM then IV crossover |
| SPL026 IMAlso: DMTIM dosing | Drug | Psychedelic Experienced IM then IV crossover, Psychedelic Naive IM dosing only |
Primary outcome
Lab biochemistry [Safety & Tolerability]
Time frame: Change from baseline at Day 1 post dose
Values of potential clinical importance
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Throughout the study until 14 days after dosing (Day 15 EOS)
Adverse Events (AEs)
Heart Rate [Vital Signs - Safety & Tolerability]
Time frame: Change from baseline heart rate at Day 1 or Day 2 post dose
pulse rate will be measured in bpm
Blood Pressure [Vital Signs - Safety & Tolerability]
Time frame: Change from baseline blood pressure at Day 1 or Day 2 post dose
arterial blood pressure
Temperature [Vital Signs - Safety & Tolerability]
Time frame: Change from baseline temperature at Day 1 or Day 2 post dose
tympanic temperature
12-lead ECG [Safety & Tolerability]
Time frame: Change from baseline ECG at Day 1 or Day 2 post dose
QTcX intervals
Physical Exam [Safety & Tolerability]
Time frame: Change from baseline at Day 1 post dose
Full physical exam screening and a brief symptom guided exam at Day -1 and Day 1
Beck Scale for Suicidal Ideation (BSS) - [Safety & Tolerability]
Time frame: Change from baseline at Day 15 post dose
The Beck Suicidal Ideation scale to monitor suicidal ideation
3 secondary outcomes
Evaluation of plasma levels of DMT
Time frame: Day 1
Mystical Experience Questionnaire (MEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]
Time frame: Day 1 (dosing day)
Challenging Experience Questionnaire (CEQ) - [Pharmacodynamics - Psychometric Scales and Questionnaires]
Time frame: Day 1 (dosing day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Location of Clinical Study Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan for this yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeep Puri, MD principal investigator
HMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPL026 IV and SPL026 IM in people with Major Depressive Disorder, run by Small Pharma Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lab biochemistry [Safety & Tolerability] (time frame: Change from baseline at Day 1 post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.