Healthy volunteers test new drug AJ302-IM for safety
NCT ID NCT06625541
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug, AJ302-IM, in 57 healthy adults to see if it is safe and how the body processes it. Participants received a single injection of either the drug or a placebo. The goal was to check for side effects and measure drug levels in the blood, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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57 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
AnnJi Investigational Site
Miami, Florida, 33136, United States
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