Recruiting
Phase 1

AJ201

Sponsor:

AnnJi Pharmaceutical Co., Ltd.

Code:

NCT07549919

Conditions

Healthy Male Adults

Food Effect in Healthy Volunteers

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

AJ201

Study Details

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

Study ID

NCT07549919

Start date

Apr 9, 2026

Status verified date

Apr, 2026

Completion date

Apr 27, 2026

Anticipated

Primary completion date

Apr 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (Japanese)

Japanese Participants

experimental: Arm B (White)

White Participants

Interventions

AJ201

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

Primary outcome measure

  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]
  • Urine PK of AJ201 [ Time Frame: Pre-dose to Day 7 ]

Central Contacts and Locations

Central contacts

Andy Chen, PhD

+886223655677andy.chen@ajpharm.com

Locations

AnnJi Investigational Site

Recruiting

Los Alamitos, California, United States, 90720

Contacts

CNS Outreach

844-424-9494cns.outreach@cenexel.com

More Information

Sponsor

AnnJi Pharmaceutical Co., Ltd.

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Healthy Male Adults
  • Healthy Volunteers
  • Food Effect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AnnJi Pharmaceutical Co., Ltd. on 2026-04-24.