Mental Health DisordersPhase 1NCT06702332
Single Ascending Dose Study of MSD-001 in Healthy Participants
A Phase 1 study testing MSD-001 in people with Mental Health Disorders, run by Mindstate Design Labs at 1 site in Netherlands.
Trial summary
The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorders
- What is being tested?
- MSD-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2024to 11 Jul 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential, Adaptive Single Ascending Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Orally Administered MSD-001 in Healthy Participants.
The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.
Read the detailed description
This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.
- Conditions
- Mental Health Disorders
- Being tested
- MSD-001, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSD-001Drug
MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications
Placebo ComparatorDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: MSD-001 | Active comparator | Planned doses of MSD-001; N = 42 Receives: Drug: MSD-001 |
| Placebo Comparator | Placebo comparator | Non-active study drug N = 10 Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, clinically significant changes in lab parameters, ECG, and vital signs
Measured: up to 30 days
Secondary outcomes (5)
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for Cmax analyzed
Measured: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for Tmax analyzed
Measured: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for AUC analyzed
Measured: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for T1/2 analyzed
Measured: Pre-dose and up to 24 hours post dose
5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)
Participants will be asked to reflect on the previous days' subjective experience using 5D-ASC rating scale.
Measured: Pre-dose and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start11 Nov 2024
- Primary completion19 Jun 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisordersStudies 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
- Model description
- In Part 1, Participants (n=8) will be randomized to receive either MSD-001 or placebo (6 active: 2 placebo) in each of 5 ascending dose levels (cohorts). In Part 2, Participants (n=4) with a CYP2D6 poor metabolizing phenotype will all receive MSD-001 (4 active: 0 placebo) in each of 3 ascending dose levels (cohorts).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mindstate Design Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Jacobs, MD, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702332
- Sponsor's protocol ID
- MSD001-NL-001
- Other IDs
- 2024-512939-67-00
- Status last verified
- Jan 2025
- First submitted
- 11 Nov 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential, Adaptive Single Ascending Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Orally Administered MSD-001 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT06702332
- Acronym / sponsor ID
- MSD001-NL-001
- Conditions
- Mental Health Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Mindstate Design LabsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 22 Nov 2024 (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 purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.
Detailed description
This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In Part 1, Participants (n=8) will be randomized to receive either MSD-001 or placebo (6 active: 2 placebo) in each of 5 ascending dose levels (cohorts). In Part 2, Participants (n=4) with a CYP2D6 poor metabolizing phenotype will all receive MSD-001 (4 active: 0 placebo) in each of 3 ascending dose levels (cohorts).
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: MSD-001 | Active comparator | Drug: MSD-001Planned doses of MSD-001; N = 42 |
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorNon-active study drug N = 10 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (8 listed)
- 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.
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 |
|---|---|---|
| MSD-001MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications | Drug | Active Treatment: MSD-001 |
| Placebo ComparatorMatching Placebo | Drug | Placebo Comparator |
Primary outcome
Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events
Time frame: up to 30 days
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, clinically significant changes in lab parameters, ECG, and vital signs
5 secondary outcomes
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)
Time frame: Pre-dose and up to 24 hours post dose
5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)
Time frame: Pre-dose and 24 hours post dose
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 16 Sep 2025.
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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 Drug 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 MSD-001 in people with Mental Health Disorders, run by Mindstate Design Labs 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 3 inclusion and 8 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 16 Sep 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?
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?
Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events (time frame: up to 30 days). 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 16 Sep 2025.