Active — Not RecruitingPhase 1

Single and Repeat Doses of DMT in Healthy Subjects

Netherlands60 participantsStarted 2023-01-13

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.
✕. 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).

What they're measuring

Safety and Tolerability: Proportion of subjects with abnormal vital signs

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Part A: Up to 2 days post infusion; Part B: Up to 12 days post first infusion

Trial details

NCT IDNCT05559931

SponsorAlgernon Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range18 Years – 60 Years

SexALL

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 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.
✕. 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).