Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGAJ302-IM
7 cohorts (7 dose levels) of participants are planned to be dosed.
DRUGPlacebo
Matching placebo
Sponsors
AnnJi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and proportion of volunteers with AEs including TEAEs and SAEs | Baseline up to Day 57 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK of AJ302-IM | Pre-dose to Day 57 | AUC0-168hr: Area under the plasma concentration-time curve from zero to 168 hours |
| Urine PK of AJ302-IM | Pre-dose to Day 8 | Ae0-168hr: Cumulative urinary excretion from time zero to 168 hours, calculated as the sum of the amounts excreted over each collection interval |
Countries
United States
Outcome results
None listed