A Study to Assess NEU-411 in Healthy Participants

NCT05755191 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NEU-411-PD101
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and tolerability of single dosing, food effect and multiple oral doses of NEU-411 in healthy subjects

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

  Up to 7 days of dosing

Secondary Outcomes (9)

• PK parameter

  Up to 7 days of dosing

• PK parameter

  Up to 7 days of dosing

• PK parameter

  Up to 7 days of dosing

• PK parameter

  Up to 7 days of dosing

• PK parameter

  Up to 7 days of dosing

Study Arms (2)

NEU-411

EXPERIMENTAL

Part A: Single-ascending dose cohorts; food effect; Part B: Multiple-ascending dose cohorts (7 days)

Drug: NEU-411

Placebo

PLACEBO COMPARATOR

Part A: Single-ascending dose cohorts; food effect; Part B: Multiple-ascending dose cohorts (7 days)

Drug: Placebo

Interventions

NEU-411 DRUG

Oral Doses

NEU-411

Placebo DRUG

Oral Doses

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects for standard cohorts must be 18-80 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
• History of clinically significant abnormal chest x-ray
• Clinically significant neurologic disorder
• Contraindications to undergo a lumbar puncture (only for subjects participating in the MAD)

Sponsors & Collaborators

• Neuron23 Inc.: lead

Study Sites (1)

New Zealand Clinical Research

Christchurch, 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: February 22, 2023
• First Posted: March 6, 2023
• Study Start: May 13, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)