StrokePhase 1NCT05559931
Single and Repeat Doses of DMT in Healthy Subjects
A Phase 1 study testing N,N-Dimethyltryptamine in people with Stroke, run by Algernon Pharmaceuticals at 1 site in Netherlands.
Trial summary
This study aims to assess the safety and tolerability of single ascending, and fixed repeated doses of N,N-Dimethyltryptamine (DMT) in healthy subjects, when given by intravenous (IV) infusion. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- N,N-Dimethyltryptamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jan 2023to Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteer. Subject must be healthy based on physical examination, medical history, vital signs, and 12-lead ECG. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable.
- Subjects must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject's source documents and initialled by the sub investigator.
- Aged 18-60 years inclusive.
- A body mass index (BMI; Quetelet index) in the range 18.5-30.0 kg/m2.
- 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 their delegate.
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- 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 administration of the trial medication.
- Agree to refrain from using any psychoactive drugs from 30 days before dosing and until the last follow up visit, to refrain from using cannabis from 14 days before dosing and until the last follow up visit and to refrain from using alcoholic beverages within 24 hours of each drug administration.
Who cannot join
- Clinically relevant abnormal history, physical findings, ECG (e.g. PQ/PR interval > 210ms, presence of Left Bundle Branch Block, AV Block (second degree or higher), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or any of the following cardiovascular conditions: arrhythmia, 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,
- History of chronic or frequent migraines.
- Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min.
- Repeat measurements are permitted if values are borderline (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if requested by the investigator. Subjects 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 of > 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.
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- Presence or history of a medically diagnosed clinically significant seizure disorder.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- 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).
- Any current or previously diagnosed clinically significant mental health disorder as classified according to DSM-IV or DSM 5.
- Presence or history of drug or alcohol abuse within 1 year before Screening, or intake of more than 14 units of alcohol weekly.
- Regular use of nicotine (>5 cigarettes daily). Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year; (2) suicidal behaviours within the past year; or (3) clinical assessment of significant suicidal risk during participant interview.
- Persistent psychological effects following the previous use of psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or ketamine. Such effects might include but are not limited to anxiety, depressed mood, paranoid ideation and/or hallucinations (including hallucinogen persisting perception disorder - HPPD) or recurrent flash-backs related to use.
- First or second-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar and related disorders as classified according to DSM-IV or DSM 5.
- Habitual users of psychedelic drugs (regular use (≥every 2 weeks) over the last 12 months). Psychedelic drugs include, but are not limited to: DMT, ayahausca, LSD, mescaline, peyote, ibogaine and psilocybin (including mushroom species containing psilocybin).
- Disposition judged by the investigator (or delegate) to be incompatible with establishment of rapport with therapy team and/or safe exposure to DMT.
- Indication that the volunteer will not cooperate with the requirements of the protocol.
- Difficulty fasting or consuming standard meals.
- Subject drinks, on average, more than 8 cups of tea/coffee/cocoa/cola/caffeinated beverages (e.g., energy drink) per day.
- Evidence of drug abuse on urine testing at screening or admission. Subject has a positive test result(s) for alcohol and/or drugs of abuse (including: opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening or admission to the clinical unit.
- Positive test for hepatitis B, hepatitis C or HIV.
- Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
- Presence or history of severe adverse reaction to any drug or a history of adverse reaction to DMT and/or other serotonergic psychedelic drugs.
- Use of a prescription medicine (except oral contraceptives or hormone replacement therapy in females) during the 14 days before the first dose of trial medication or use of an over-the-counter medicine (including natural food supplements, vitamins, garlic as a supplement), during the 7 days before the first dose of trial medication, with the exception of occasional use of common analgesics, eg acetaminophen (paracetamol), ibuprofen.
- Use of MAOIs is prohibited during the 30 days before the first dose of trial medication and during the study.
- Receipt of any COVID-19 vaccination in the 7 days before the study or during the study.
- Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before [first] admission to this study and/or prior enrolment in this study; in the follow-up period of another clinical trial at the time of screening for this study. Participation in observational registry studies is permitted.
- Vulnerable subjects (e.g., a person kept in detention or a person under guardianship).
- Subject is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of Ascending Single and Fixed Repeat Intravenous Doses of DMT in Healthy Subjects
This study aims to assess the safety and tolerability of single ascending, and fixed repeated doses of N,N-Dimethyltryptamine (DMT) in healthy subjects, when given by intravenous (IV) infusion.
- Conditions
- Stroke
- Being tested
- N,N-Dimethyltryptamine, Placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N,N-DimethyltryptamineDrug
Also called DMT
IV infusion over 6 hours
PlaceboDrug
Placebo infusion over 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Dose Active | Experimental | Subjects will receive a single IV dose of DMT, administered as a bolus loading dose followed by a 6-h infusion. The starting dose will be 1.5 mg bolus, followed by a 0.105 mg/min infusion. Subsequent doses will be based on the safety and tolerability data from previous groups. Receives: Drug: N,N-Dimethyltryptamine |
| Part A: Single Dose Placebo | Placebo comparator | Subjects will receive a single IV dose of placebo, administered as a bolus loading dose followed by a 6-h infusion. Receives: Drug: Placebo |
| Part B: Multiple Dose Active | Experimental | Subjects will receive a total of 6 doses of DMT, given as a bolus loading dose, followed by a IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. Dose to be determined from single dose phase. Receives: Drug: N,N-Dimethyltryptamine |
| Part B: Multiple Dose Placebo | Placebo comparator | Subjects will receive a total of 6 doses of placebo, given as a bolus loading dose, followed by IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Proportion of subjects with abnormal vital signs
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: Proportion of subjects with abnormal ECG readings
12-lead ECG
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: Proportion of subjects with abnormal physical examination findings
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: percentage of subjects with abnormal haematology, clinical chemistry, coagulation, and urinalysis values
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: percentage of subjects with local reactions at the injection site
Measured: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with abnormal findings on the Columbia-Suicide Severity Ratings Scale (C-SSRS)
Measured: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with occurrence of psychotic symptoms (BPRS)
Measured: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with occurrence of central 5-HT toxicity
Hunters criteria + CPK
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: proportion of subjects with at least one adverse event (AE)
Measured: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Secondary outcomes (8)
DMT - Maximum Plasma Concentration (Cmax)
Measured: Up to 4 hours post infusion
DMT - Time to peak drug concentration (tmax)
Measured: Up to 4 hours post infusion
DMT - Area Under Curve last (AUClast)
Area under the plasma concentration-time curve to the last measurable plasma concentration
Measured: Up to 4 hours post infusion
DMT - Area Under Curve 0-t (AUC0-t)
Measured: Up to 4 hours post infusion
DMT - Area Under Curve infinity (AUCinf)
Measured: Up to 4 hours post infusion
DMT - %AUCextrap
Measured: Up to 4 hours post infusion
DMT - Half Life (t1/2)
Measured: Up to 4 hours post infusion
DMT - Clearance (CL)
Measured: Up to 4 hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start13 Jan 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algernon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands
- Responsible party
- Sponsor
- Investigators
- Gabriel Jacobs, MD, PhD, Principal investigator, Centre for Human Drugs Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559931
- Sponsor's protocol ID
- AGN-188-1
- Status last verified
- Jan 2025
- First submitted
- 14 Sep 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Heijden KV, Zuiker RGJA, Otto ME, Bryan CS, Stewart N, Stillwell C, De Kam ML, van Leuken MB, van Gerven JMA, Jacobs GE. Safety, Pharmacokinetics, and Pharmacodynamics of a 6-h N,N-Dimethyltryptamine (DMT) Infusion in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial. Clin Transl Sci. 2025 May;18(5):e70234. doi: 10.1111/cts.70234.
PubMed 40356576
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of Ascending Single and Fixed Repeat Intravenous Doses of DMT in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05559931
- Acronym / sponsor ID
- AGN-188-1
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Algernon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Human Drug Research, Netherlands
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Sep 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.
This study aims to assess the safety and tolerability of single ascending, and fixed repeated doses of N,N-Dimethyltryptamine (DMT) in healthy subjects, when given by intravenous (IV) infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Dose Active | Experimental | Drug: N,N-DimethyltryptamineSubjects will receive a single IV dose of DMT, administered as a bolus loading dose followed by a 6-h infusion. The starting dose will be 1.5 mg bolus, followed by a 0.105 mg/min infusion. Subsequent doses will be based on the safety and tolerability data from previous groups. |
| Part A: Single Dose Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single IV dose of placebo, administered as a bolus loading dose followed by a 6-h infusion. |
| Part B: Multiple Dose Active | Experimental | Drug: N,N-DimethyltryptamineSubjects will receive a total of 6 doses of DMT, given as a bolus loading dose, followed by a IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. Dose to be determined from single dose phase. |
| Part B: Multiple Dose Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a total of 6 doses of placebo, given as a bolus loading dose, followed by IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female volunteer. Subject must be healthy based on physical examination, medical history, vital signs, and 12-lead ECG. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable.
- Subjects must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the subject's source documents and initialled by the sub investigator.
- Aged 18-60 years inclusive.
- A body mass index (BMI; Quetelet index) in the range 18.5-30.0 kg/m2.
- 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.
Key exclusion criteria (29 listed)
- Clinically relevant abnormal history, physical findings, ECG (e.g. PQ/PR interval > 210ms, presence of Left Bundle Branch Block, AV Block (second degree or higher), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or any of the following cardiovascular conditions: arrhythmia, 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,
- History of chronic or frequent migraines.
- Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min.
- Repeat measurements are permitted if values are borderline (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if requested by the investigator. Subjects can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator.
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 |
|---|---|---|
| N,N-DimethyltryptamineAlso: DMTIV infusion over 6 hours | Drug | Part A: Single Dose Active, Part B: Multiple Dose Active |
| PlaceboPlacebo infusion over 6 hours | Drug | Part A: Single Dose Placebo, Part B: Multiple Dose Placebo |
Primary outcome
Safety and Tolerability: Proportion of subjects with abnormal vital signs
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: Proportion of subjects with abnormal ECG readings
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
12-lead ECG
Safety and Tolerability: Proportion of subjects with abnormal physical examination findings
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: percentage of subjects with abnormal haematology, clinical chemistry, coagulation, and urinalysis values
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Safety and Tolerability: percentage of subjects with local reactions at the injection site
Time frame: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with abnormal findings on the Columbia-Suicide Severity Ratings Scale (C-SSRS)
Time frame: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with occurrence of psychotic symptoms (BPRS)
Time frame: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion
Safety and Tolerability: proportion of subjects with occurrence of central 5-HT toxicity
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
Hunters criteria + CPK
Safety and Tolerability: proportion of subjects with at least one adverse event (AE)
Time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion
8 secondary outcomes
DMT - Maximum Plasma Concentration (Cmax)
Time frame: Up to 4 hours post infusion
DMT - Time to peak drug concentration (tmax)
Time frame: Up to 4 hours post infusion
DMT - Area Under Curve last (AUClast)
Time frame: Up to 4 hours post infusion
DMT - Area Under Curve 0-t (AUC0-t)
Time frame: Up to 4 hours post infusion
DMT - Area Under Curve infinity (AUCinf)
Time frame: Up to 4 hours post infusion
DMT - %AUCextrap
Time frame: Up to 4 hours post infusion
DMT - Half Life (t1/2)
Time frame: Up to 4 hours post infusion
DMT - Clearance (CL)
Time frame: Up to 4 hours post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Derived from this study: PubMed 40356576van der Heijden KV, Zuiker RGJA, Otto ME, Bryan CS, Stewart N, Stillwell C, De Kam ML, van Leuken MB, van Gerven JMA, Jacobs GE. Safety, Pharmacokinetics, and Pharmacodynamics of a 6-h N,N-Dimethyltryptamine (DMT) Infusion in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial. Clin Transl Sci. 2025 May;18(5):e70234. doi: 10.1111/cts.70234.
- Individual participant dataSharing planned: Undecided
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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.
Gabriel Jacobs, MD, PhD principal investigator
Centre for Human Drugs Research
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 N,N-Dimethyltryptamine in people with Stroke, run by Algernon Pharmaceuticals at 1 site in Netherlands.
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 9 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Tolerability: Proportion of subjects with abnormal vital signs (time frame: Part A: Up to 10 days post infusion; Part B: Up to 21 days post first infusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559931, which also lists 1 linked publication.
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 28 Jan 2025.