NCT06702332

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Mindstate Design Labs · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mental Health Disorders

Interventions

Type	Name	Description
DRUG	MSD-001	MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications
DRUG	Placebo Comparator	Matching Placebo

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-06-19
• Completion: 2025-07-11
• First posted: 2024-11-22
• Last updated: 2025-09-16

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study