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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AJ201 for people with food effect in healthy volunteers and healthy male adults. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAJ201

All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).


Locations(1)

AnnJi Investigational Site

Los Alamitos, California, United States

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NCT07549919


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