Evaluating 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
This study is testing a new drug called AJ302-IM in healthy volunteers to see how safe it is and how the body processes it compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AnnJi Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06625541 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM through single ascending doses administered intramuscularly to healthy volunteers. Participants will be monitored for any adverse effects and how the drug is processed in the body. The study will include both the AJ302-IM treatment and a placebo for comparison. The findings will help determine the appropriate dosing and safety profile of AJ302-IM.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 55 with a normal BMI and no significant medical history.
Not a fit: Patients with a history of significant medical conditions or those who have experienced suicidal behavior may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of AJ302-IM for future therapeutic applications.
How similar studies have performed: While this study focuses on a specific drug, similar studies evaluating pharmacokinetics and safety in healthy volunteers have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- AnnJi Investigational Site — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Andy Chen, PhD
- Email: andy.chen@ajpharm.com
- Phone: +886223655677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.