Status:
RECRUITING
A Study to Assess NEU-627 in Healthy Participants
Lead Sponsor:
Neuron23 Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 effe...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply.
- Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
- Participants must be in good general health according to the judgment of the Investigator per local guidance;
- Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
- When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
- 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.
- 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;
- Any history of malignant disease in the last 5 years;
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
- 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;
- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
- Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
- History of active, latent, or inadequately treated tuberculosis infection.
- Additional details and criteria are outlined in the full study protocol.
Exclusion
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06900751
Start Date
June 2 2025
End Date
November 1 2025
Last Update
June 13 2025
Active Locations (1)
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1
New Zealand Clinical Research
Grafton, Aukland, New Zealand, 1010