NCT05755191

A Study to Assess NEU-411 in Healthy Participants

A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of NEU-411 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Neuron23 Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), food effect (FE),multiple ascending dose (MAD), drug-drug interaction study, and bioavailability - bio-equivalence study of orally administered NEU-411 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 18-80 years, inclusive). 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). Within each cohort, 6 subjects will receive one dose of NEU-411, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based on available safety and PK data. Food effect will evaluate approximately 8 subjects in a fasted versus fed state. Multiple ascending oral doses will be administered up to 24 healthy subjects (aged 18 - 80 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-411 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 7 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 on available safety and PD data. Multiple oral dosing will be administered in up to 39 healthy subjects in 3 sequential dosing groups (13 subjects across 3 dosing groups) over 28 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	NEU-411	Oral Doses
DRUG	Placebo	Oral Doses

Timeline

• Start date: 2023-05-13
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2023-03-06
• Last updated: 2025-02-24

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study