Single Ascending Dose Study of MSD-001 in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Disorders
• Intervention / Treatment: Drug: Placebo Comparator; Drug: MSD-001

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands
      • Centre For Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Treatment: MSD-001; Planned doses of MSD-001; N = 42	Drug: MSD-001; MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications
Placebo Comparator: Placebo Comparator; Non-active study drug N = 10	Drug: Placebo Comparator; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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.	Pre-dose and 24 hours post dose

Collaborators and Investigators

• Sponsor: Mindstate Design Labs
• Investigators: Principal Investigator: Gabriel Jacobs, MD, PhD, Centre For Human Drug Research

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): June 19, 2025
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: MSD001-NL-001; 2024-512939-67-00 (Ctis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No