Clinical trial NCT06702332: Single Ascending Dose Study of MSD-001 in Healthy Participants
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mental Health Disorders
Lead sponsor: Mindstate Design Labs
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
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
timeFrame: up to 30 days
Secondary outcomes:
measure: Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)
timeFrame: Pre-dose and up to 24 hours post dose
measure: Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)
timeFrame: Pre-dose and up to 24 hours post dose
measure: Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)
timeFrame: Pre-dose and up to 24 hours post dose
measure: Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)
timeFrame: Pre-dose and up to 24 hours post dose
measure: 5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)
timeFrame: Pre-dose and 24 hours post dose
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
state: Zuid-Holland
Study officials:
affiliation: Centre for Human Drug Research
name: Gabriel Jacobs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: