Healthy
Conditions
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.
Interventions
DRUGNEU-627
Investigational medicinal product
OTHERPlacebo
Placebo
Sponsors
Neuron23 Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants | Up to 10 days of dosing | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627 | Up to 10 days of dosing |
| NEU-627 concentrations | Up to 10 days of dosing |
| Change from baseline of the corrected QT interval | Up to 10 days of dosing |
Countries
New Zealand
Outcome results
None listed