Clinical trial NCT06500442: A Study to Assess NEU-111 in Healthy Participants
Official title: A Phase 1 Study of NEU-111 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Neuron23 Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Up to five (5) single-ascending oral doses will be administered to 40 healthy adult male or female subjects, (aged 18-64 years, inclusive). Escalation to the next higher dose level may occur only after evaluation of the safety and available PK results of the previous dose level (at least 6 evaluable subjects). Within each cohort, 6 subjects will receive one dose of NEU-111, and 2 subjects will receive one dose of matching placebo. Dose levels may be revised based upon available safety and PK data.

Multiple ascending oral doses will be administered up to 24 healthy subjects, (aged 18-64 years, inclusive) in 3 sequential dosing groups (8 subjects in each dosing group). Six (6) subjects will receive NEU-111 and two (2) subjects will receive matching placebo in each dosing group (cohort) for 10 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 upon available safety and PK data.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

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;

Exclusion Criteria:

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;

Primary outcomes:
measure: Evaluate the safety and tolerability of single and multiple oral doses of NEU-111 in healthy subjects
timeFrame: Up to 10 days of dosing
Secondary outcomes:
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
measure: PK Parameter
timeFrame: Up to 10 days of dosing
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
References: