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

NCT07549919 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JM17-201-102
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Adults; Food Effect in Healthy Volunteers

Keywords

Healthy Male Adults; Healthy Volunteers; Food Effect

Outcome Measures

Primary Outcomes (17)

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

  Cmax: Maximal observed concentration under fasting and fed conditions

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

  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

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Plasma PK of AJ201

  Kel: Terminal elimination rate constant under fasting and fed conditions

  Pre-dose to Day 6

• Plasma PK of AJ201

  Cl/F: Apparent clearance under fasting and fed conditions

  Pre-dose to Day 6

• Plasma PK of AJ201

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

  Pre-dose to Day 6

• Urine PK of AJ201

  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

  Pre-dose to Day 7

• Urine PK of AJ201

  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

  Pre-dose to Day 7

• Urine PK of AJ201

  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

  Pre-dose to Day 7

• Urine PK of AJ201

  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

  Pre-dose to Day 7

• Urine PK of AJ201

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

  Pre-dose to Day 7

• Urine PK of AJ201

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

  Pre-dose to Day 7

Secondary Outcomes (1)

• Safety and Tolerability of AJ201

  Baseline to Day 12

Study Arms (2)

Arm A (Japanese)

EXPERIMENTAL

Japanese Participants

Drug: AJ201

Arm B (White)

EXPERIMENTAL

White Participants

Drug: AJ201

Interventions

AJ201 DRUG

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

Arm A (Japanese); Arm B (White)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnnJi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

AnnJi Investigational Site

Los Alamitos, California, 90720, United States

RECRUITING

Central Study Contacts

Andy Chen, PhD

CONTACT

+886223655677; andy.chen@ajpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: April 9, 2026
• Primary Completion: April 22, 2026
• Study Completion: April 27, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)