A Study to Assess NEU-627 in Healthy Participants

NCT06900751 | Completed Phase 1 DMC

• 1 other identifier: NEU-627-MS101
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

NEU-627

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort

Other: Placebo

Interventions

NEU-627 DRUG

Investigational medicinal product

NEU-627

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply.
• Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
• Participants must be in good general health according to the judgment of the Investigator per local guidance;
• Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
• When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply.
• 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;
• Any history of malignant disease in the last 5 years;
• Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
• 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;
• Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
• Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
• History of active, latent, or inadequately treated tuberculosis infection.
• Additional details and criteria are outlined in the full study protocol.

Sponsors & Collaborators

• Neuron23 Inc.: lead

Study Sites (1)

New Zealand Clinical Research

Grafton, Aukland, 1010, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 28, 2025
• Study Start: June 2, 2025
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

NZ (1)