A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers
- Registration Number
- NCT06625541
- Lead Sponsor
- AnnJi Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
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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.
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Normal renal function at screening.
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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.
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Able to understand the study procedures and provide signed informed consent to participate in the study
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description AJ302-IM AJ302-IM - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Incidence and proportion of volunteers with AEs including TEAEs and SAEs Baseline up to Day 57
- Secondary Outcome Measures
Name Time Method Plasma PK of AJ302-IM Pre-dose to Day 57 Vz/F: Apparent volume of distribution
Urine PK of AJ302-IM Pre-dose to Day 8 ClR: Renal clearance, calculated as Ae0-168hr /AUC0-168hr
Trial Locations
- Locations (1)
AnnJi Investigational Site
🇺🇸Miami, Florida, United States