A Study to Assess NEU-411 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05755191
• Other study ID #: NEU-411-PD101
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2023
• Est. completion date: June 2, 2024

Study information

• Verified date: June 2024
• Source: Neuron23 Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: June 2, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NEU-411
Oral Doses
• Placebo
Oral Doses

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Neuron23 Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK parameter	The maximum concentration (Cmax) at steady state in plasma	Up to 7 days of dosing
Secondary	PK parameter	The area under the concentration-time curve from zero to infinity (AUC0-inf) in plasma	Up to 7 days of dosing
Secondary	PK parameter	The time to reach maximum concentration (tmax) in plasma	Up to 7 days of dosing
Secondary	PK parameter	Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) in plasma	Up to 7 days of dosing
Secondary	PK parameter	Apparent terminal elimination half-life (t1/2) in plasma	Up to 7 days of dosing
Secondary	PK parameter	The terminal elimination rate constant (?Z) with the respective half-life (t½) in plasma	Up to 7 days of dosing
Secondary	PK parameter	The oral clearance (CL/F)	Up to 7 days of dosing
Secondary	PK parameter	The volume of distribution (Vd/F)	Up to 7 days of dosing
Secondary	PK parameter	The area under the concentration-time curve over a dosing interval (AUC0-t) in plasma (multiple dosing only)	Up to 7 days of dosing