A Study to Assess NEU-627 in Healthy Participants

Launched by NEURON23 INC. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is evaluating a new medication called NEU-627 in healthy individuals. The main goal of this study is to check how safe the medication is, how well it works in the body, and how food might affect its absorption. This is a Phase 1 trial, which means it’s one of the first steps in testing a new drug in people. The trial will involve healthy adults aged 18 to 60 years, who are in good health and have a body mass index (BMI) between 18 and 32. Participants will be randomly assigned to receive either NEU-627 or a placebo (a substance with no active drug) without knowing which one they are getting.

If you are considering participating, you should know that you will need to be in good health overall and not have any significant medical conditions that could affect the study. You'll also need to follow specific guidelines regarding contraception if you are a man with a female partner. Participants can expect to undergo various assessments to monitor their health during the study. It’s important to note that this trial is not yet recruiting participants, so you would need to wait until it starts.

Gender

ALL

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.