NCT06900751

A Study to Assess NEU-627 in Healthy Participants

A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Neuron23 Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.

Detailed description

This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	NEU-627	Investigational medicinal product
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-06-02
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2025-03-28
• Last updated: 2026-01-15

Locations

1 site across 1 country: New Zealand