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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: NEU-627

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Aukland
    • Grafton, Aukland, New Zealand, 1010
      • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply.

1. Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
2. Participants must be in good general health according to the judgment of the Investigator per local guidance;
3. Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
4. When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
5. Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply.

1. Clinically significant infection and/or dermatological, cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if he/she were to participate in the study;
2. Any history of malignant disease in the last 5 years;
3. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
4. Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or within 3 months prior to the first study drug administration;
5. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
6. Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
7. History of active, latent, or inadequately treated tuberculosis infection.

Additional details and criteria are outlined in the full study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEU-627; Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort; Part C: Open-label, food effect evaluation; and Part D: Open-label, determination of cerebrospinal concentration	Drug: NEU-627; Investigational medicinal product
Experimental: Placebo; Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 10 days of dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627	Up to 10 days of dosing
NEU-627 concentrations	Up to 10 days of dosing
Change from baseline of the corrected QT interval	Up to 10 days of dosing

Collaborators and Investigators

• Sponsor: Neuron23 Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NEU-627-MS101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No