A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers

Exclusion Criteria

• •Any clinically significant abnormal finding at physical examination
• •Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
• •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 pregnancy test or lactating female volunteers
• •Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
• •History of significant allergic reactions to any drug
• •Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or its derivatives and/or any study product excipients
• •Clinically significant ECG abnormalities or vital signs abnormalities at screening
• •History of drug abuse or recreational use of soft drugs or hard drugs
• •History of alcohol abuse
• •History of smoking or uses other nicotine-containing products
• •Undergone major surgery ≤ 2 months before 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
• •Received any investigational drug or any investigational device or any biological product within the timeframes specified in the protocol
• •Tattoos, sunburn, scarring or anything that may interfere with evaluation of the injection site