A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

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.