Testing MSD-001 for safety and effects in healthy adults

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.

This study is testing a new drug called MSD-001 in healthy adults to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Mindstate Design Labs (Industry-sponsored)
• Locations: 1 site (Leiden, Zuid-Holland)
• Trial ID: NCT06702332 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001 in healthy adult participants. It is a first-in-human, double-blind, placebo-controlled trial that uses a single ascending dose approach. Participants will be stratified based on their CYP2D6 phenotype, and the study will take place at a single center. The goal is to gather data on how the drug behaves in the body and its potential effects.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 with established CYP2D6 phenotypes.

Not a fit: Patients with current or past psychiatric disorders or significant cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for mental health disorders.

How similar studies have performed: Other studies have shown success with similar approaches in evaluating new treatments for mental health conditions.

Eligibility criteria

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.

Where this trial is running

Leiden, Zuid-Holland

• Centre for Human Drug Research — Leiden, Zuid-Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Gabriel Jacobs, MD, PhD — Centre for Human Drug Research
• Study coordinator: Jasminder Soto

Conditions Mental Health Disorders