New drug MSD-001 tested in healthy volunteers for safety
NCT ID NCT06702332
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage trial tested a single dose of MSD-001 in 47 healthy adults to see if it is safe and how the body processes it. The drug is being developed as part of a future combination treatment for mental health conditions. The study is now complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MSD-001
- What this could lead to
- If successful, this study could pave the way for developing a new treatment for mental health disorders.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. It only tests safety and dosing, not whether the drug works for any condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
47 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
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Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Male or female healthy consented participants 18 to 55 years of age * CYP2D6 phenotype established based on pharmacogenetic testing. * Free from psychoactive drug use from 4 weeks before dosing and until the last follow up visit. Key Exclusion Criteria: * Any current clinically relevant, or history of, acute or chronic diseases inclusive of psychiatric disorders and relevant family history, which could interfere with the participant's safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. * Moderate to severe congestive heart failure, history of heart surgery, pulmonary hypertension, systemic hypertension (i.e., systolic BP \>139 mm hg, diastolic blood pressure \> 89 mm hg), pulse rate \> 90 bpm, clinically significant ECG abnormality, QTc \> 450 msec, myocardial infarction in the past year, or any other active or severe cardiovascular condition. * Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure. * Use of any psychedelic drug in the three months prior to planned dosing or the occurrence of persistent psychological effects following the previous use of psychedelic drugs. * Subject experiences severe anticipatory anxiety or is otherwise considered unfit for study. * History of moderate or severe illicit substance abuse or dependence, or a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit. * Subject has received a prior investigational intervention, has had a history of relevant hypersensitivity or allergic reactions, and has donated and/or received any blood or blood products or experienced blood loss, that may interfere with the objectives of the study. * Subject has a significant negative life event (e.g. loss of a loved one) in the past 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre for Human Drug Research
Leiden, South Holland, Netherlands
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