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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Male Adults; Food Effect in Healthy Volunteers
• Intervention / Treatment: Drug: AJ201

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andy Chen, PhD; Phone Number: 801 +886223655677; Email: andy.chen@ajpharm.com

Study Locations

• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • AnnJi Investigational Site
      • Contact: CNS Outreach; Phone Number: 844-424-9494; Email: cns.outreach@cenexel.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (Japanese); Japanese Participants	Drug: AJ201; All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Experimental: Arm B (White); White Participants	Drug: AJ201; All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of AJ201	Incidence and proportion of volunteers with AEs, including TEAEs and SAEs	Baseline to Day 12

Collaborators and Investigators

• Sponsor: AnnJi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2026
• Primary Completion (Estimated): April 22, 2026
• Study Completion (Estimated): April 27, 2026

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Food Effect; Healthy Male Adults
• Other Study ID Numbers: JM17-201-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No