Phase
Condition
Healthy Volunteers
Treatment
Placebo
AJ302-IM
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male or female, non-smokers (no use of tobacco or nicotine products within 3 monthsprior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5and ≤ 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 priorto study drug administration.
The absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological, psychiatric,depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolicdisease.
Able to understand the study procedures and provide signed informed consent toparticipate in the study
Exclusion
Key Exclusion Criteria:
Any clinically significant abnormal finding at physical examination
Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidalideation with some intent to act, without specific plan) or type 5 (active suicidalideation with specific plan and intent) in the 2 years before screening based on theC-SSRS
Clinically significant abnormal laboratory test results or positive serology testresults 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 screeningand on Day -1
History of significant allergic reactions to any drug
Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or itsderivatives 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 infectionor 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 biologicalproduct within the timeframes specified in the protocol
Tattoos, sunburn, scarring or anything that may interfere with evaluation of theinjection site
Study Design
Connect with a study center
AnnJi Investigational Site
Miami, Florida 33136
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.