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Clinical Trials/NCT07549919
NCT07549919RecruitingPhase 1

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

AnnJi Pharmaceutical Co., Ltd.1 site in 1 country26 target enrollmentStarted: April 9, 2026Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
26
Locations
1
Primary Endpoint
Plasma PK of AJ201

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

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.

Arms & Interventions

Arm A (Japanese)

Experimental

Japanese Participants

Intervention: AJ201 (Drug)

Arm B (White)

Experimental

White Participants

Intervention: AJ201 (Drug)

Outcomes

Primary Outcomes

Plasma PK of AJ201

Time Frame: Pre-dose to Day 6

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

Urine PK of AJ201

Time Frame: Pre-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

Secondary Outcomes

  • Safety and Tolerability of AJ201(Baseline to Day 12)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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