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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of AJ302-IM in Healthy Volunteers Via Intramuscular Injection

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers.

Key Inclusion Criteria:

• Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.

• 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 clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.

• 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
• 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