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Study of AJ201 in Healthy Men

This study is looking at a drug called AJ201 to see how your body handles it, especially whether food changes how much of the drug gets into your system. Researchers also want to understand if AJ201 is safe and well-tolerated. You might be able to join if you are a healthy man, between 18 and 55 years old, and meet other health requirements like having normal kidney function. The study aims to enroll 26 participants. The main goal is to measure the levels of AJ201 in your blood over a period of up to 6 days after you take the drug.

Study design
This is a Phase 1, randomized, single-dose, open-label study involving 26 healthy male participants. It's designed to compare how AJ201 works when taken with food versus without food.
What's involved
All participants will receive a single dose of AJ201 during two different periods (once with food and once without). Your blood will be tested from before you take the drug up to 6 days later.
Compensation
Not stated in the trial record.
Follow-up
Your blood levels of AJ201 will be measured from before you take the drug up to 6 days after each dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07549919

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
AnnJi Pharmaceutical Co., Ltd.
~26 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:AJ201

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Plasma PK of AJ201
Measured over Pre-dose to Day 6
+16 more outcomes measured

Conditions

Healthy Male Adults
Food Effect in Healthy Volunteers

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
California1

Who to contact

Andy Chen, PhD
[email protected]
+886223655677 · ext. 801
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Plasma PK of AJ201Pre-dose to Day 6

    AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Cmax: Maximal observed concentration under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Tmax: Time when the maximal concentration is observed under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-last/AUC0-inf)\] x 100 under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Tlag: Time of observation prior to the first observation with a measurable (non-zero) concentration under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    T½ el: Terminal elimination half-life under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Kel: Terminal elimination rate constant under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Cl/F: Apparent clearance under fasting and fed conditions

  • Plasma PK of AJ201Pre-dose to Day 6

    Vz/F: Apparent volume of distribution under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    Ae0-24hr: Cumulative urinary excretion from time zero to 24 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    Ae0-48hr: Cumulative urinary excretion from time zero to 48 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    Ae0-last: Cumulative urinary excretion from time zero to the last observed concentrations, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred under fasting and fed conditions

  • Urine PK of AJ201Pre-dose to Day 7

    ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions