Clinical trial NCT06900751: A Study to Assess NEU-627 in Healthy Participants
Official title: A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Neuron23 Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.

Eligibility criteria: Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply.

1. Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
2. Participants must be in good general health according to the judgment of the Investigator per local guidance;
3. Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
4. When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
5. 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.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply.

1. 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;
2. Any history of malignant disease in the last 5 years;
3. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
4. 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;
5. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
6. Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
7. History of active, latent, or inadequately treated tuberculosis infection.

Additional details and criteria are outlined in the full study protocol.

Primary outcomes:
measure: Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
timeFrame: Up to 10 days of dosing
Secondary outcomes:
measure: Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627
timeFrame: Up to 10 days of dosing
measure: NEU-627 concentrations
timeFrame: Up to 10 days of dosing
measure: Change from baseline of the corrected QT interval
timeFrame: Up to 10 days of dosing
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research
state: Aukland
Study officials:
References: