New drug AJ201: does food change how it works?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg. * Normal renal function at Screening. * Healthy as defined by: * The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration. * The absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease. * Participants must be either Japanese or White. * Able to understand the study procedures and provide signed informed consent to participate in the study. Key Exclusion Criteria: * Any clinically significant abnormal finding at physical examination. * Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening. * Positive urine drug screen, urine cotinine test, or alcohol breath test. * History of significant allergic reactions to any drug. * Clinically significant ECG abnormalities or vital signs abnormalities at Screening. * History of drug abuse of any soft drugs or hard drugs. * History of alcohol abuse. * History of smoking or uses other nicotine-containing products. * Undergone major surgery ≤ 3 months before first study drug administration. * History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma or any current infection. * Use of medications for the timeframes specified in the protocol. * Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.