Food effects on AJ201 absorption and safety in healthy Japanese and White men.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, single-dose, two-way crossover Phase 1 study enrolls healthy Japanese and White male volunteers to compare AJ201 given with and without food. Each participant receives two treatments in different periods with a washout between doses, and blood samples are taken to measure pharmacokinetic parameters. Safety and tolerability are monitored by vital signs, laboratory tests, and adverse event reporting throughout the study. Results will define any food-related changes in absorption and provide initial safety data to guide later clinical development.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg.
* 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 a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
* Participants must be either Japanese or White.
* 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.
* 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 urine drug screen, urine cotinine test, or alcohol breath test.
* History of significant allergic reactions to any drug.
* Clinically significant ECG abnormalities or vital signs abnormalities at Screening.
* History of drug abuse of any soft drugs or hard drugs.
* History of alcohol abuse.
* History of smoking or uses other nicotine-containing products.
* Undergone major surgery ≤ 3 months before first 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.
* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.

Where it's running

• AnnJi Investigational Site
  Los Alamitos, California, United States Recruiting

Study contacts

• Study coordinator: Andy Chen, PhD
• Email: andy.chen@ajpharm.com
• Phone: +886223655677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.