NCT06500442

A Study to Assess NEU-111 in Healthy Participants

A Phase 1 Study of NEU-111 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Neuron23 Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD), of orally administered NEU-111 in healthy subjects.

Detailed description

Up to five (5) single-ascending oral doses will be administered to 40 healthy adult male or female subjects, (aged 18-64 years, inclusive). Escalation to the next higher dose level may occur only after evaluation of the safety and available PK results of the previous dose level (at least 6 evaluable subjects). Within each cohort, 6 subjects will receive one dose of NEU-111, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based upon available safety and PK data. Multiple ascending oral doses will be administered up to 24 healthy subjects, (aged 18-64 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-111 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 10 days. Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level (at least 6 evaluable subjects). Dose levels may be revised based upon available safety and PK data.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	NEU-111	Oral Doses
DRUG	Placebo	Oral Doses

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-02-22
• Completion: 2025-02-22
• First posted: 2024-07-15
• Last updated: 2025-07-28

Locations

1 site across 1 country: New Zealand