Single Ascending Dose Study of MSD-001 in Healthy Participants

NCT06702332 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: MSD001-NL-0012024-512939-67-00
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)

  Pre-dose and up to 24 hours post dose

• Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)

  Pre-dose and up to 24 hours post dose

• Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)

  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)

  Pre-dose and up to 24 hours post dose

• 5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)

  Pre-dose and 24 hours post dose

Study Arms (2)

Active Treatment: MSD-001

ACTIVE COMPARATOR

Planned doses of MSD-001; N = 42

Drug: MSD-001

Placebo Comparator

PLACEBO COMPARATOR

Non-active study drug N = 10

Drug: Placebo Comparator

Interventions

MSD-001 DRUG

MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications

Active Treatment: MSD-001

Placebo Comparator DRUG

Matching Placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mindstate Design Labs: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, South Holland, Netherlands

Location

Study Officials

• Gabriel Jacobs, MD, PhD

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 22, 2024
• Study Start: November 11, 2024
• Primary Completion: June 19, 2025
• Study Completion: July 11, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-01

Locations

NL (1)