RecruitingPhase 1NCT07549919

A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

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

Sponsor

AnnJi Pharmaceutical Co., Ltd.

Enrollment

26 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

Food Effect in Healthy Volunteers Healthy Male Adults

Summary

This is 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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

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.

Exclusion Criteria12

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.