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

A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

This test checks whether taking AJ201 with food changes how the drug is absorbed and whether it is safe in healthy Japanese and White men.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: AnnJi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Los Alamitos, California)
• Trial ID: NCT07549919 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy Japanese or White men aged 18–55 who are non-smokers, weigh at least 50 kg, have a BMI of 18.5–30 kg/m2, and have normal renal function.

Not a fit: Women, people outside the age or BMI ranges, current or recent smokers, those with significant medical conditions, or non-Japanese/White individuals are not eligible and would not receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the results will clarify whether food alters AJ201 absorption and safety so dosing and administration instructions can be set for future patient studies.

How similar studies have performed: Food-effect crossover pharmacokinetic studies in healthy volunteers are a routine, well-established method and have been used successfully to detect absorption changes for many drugs, although findings vary by compound.

Eligibility criteria

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 this trial is running

Los Alamitos, California

• AnnJi Investigational Site — Los Alamitos, California, United States (Recruiting)

Study contacts

• Study coordinator: Andy Chen, PhD

Conditions Healthy Male Adults; Food Effect in Healthy Volunteers; Healthy Volunteers; Food Effect