A Study to Assess NEU-111 in Healthy Participants

NCT06500442 | Completed Phase 1 DMC

• 1 other identifier: NEU-111-UC101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of single and multiple oral doses of NEU-111 in healthy subjects

  Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 10 days of dosing

Secondary Outcomes (9)

• PK Parameter

  Up to 10 days of dosing

• PK Parameter

  Up to 10 days of dosing

• PK Parameter

  Up to 10 days of dosing

• PK Parameter

  Up to 10 days of dosing

• PK Parameter

  Up to 10 days of dosing

Study Arms (2)

NEU-111

EXPERIMENTAL

Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort (10 days)

Drug: NEU-111

Placebo

PLACEBO COMPARATOR

Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days)

Drug: Placebo

Interventions

NEU-111 DRUG

Oral Doses

NEU-111

Placebo DRUG

Oral Doses

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects for standard cohorts must be 18-64 years, inclusive, at the time of signing the informed consent; Subjects who are in good general health with no clinically relevant abnormalities based on the medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry) Subjects who have a body mass index (BMI) of 18-32 kg/m2(inclusive);
• Male subjects are eligible to participate if they are rendered surgically sterile (at least 6 months), or agree to the following during the study and for at least 30 days after the last dose of study drug:
• Refrain from donating sperm;
• AND, either:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception as a condom may break or leak when having sexual intercourse;
• Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to one of the following:
• Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to use an acceptable, highly effective contraceptive method from Screening until 30 days after the last dose of study treatment (see Section 11.3); OR Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile) and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1;

You may not qualify if:

• History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia; Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration;

Sponsors & Collaborators

• Neuron23 Inc.: lead

Study Sites (1)

New Zealand Clinical Research

Auckland, 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: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 17, 2024
• Primary Completion: February 22, 2025
• Study Completion: February 22, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

NZ (1)