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
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A (Japanese) |
Japanese Participants |
|
|
Experimental Arm B (White) |
White Participants |
|
Recruiting Locations
AnnJi Investigational Site
Los Alamitos, California 90720
Los Alamitos, California 90720
More Details
- Status
- Recruiting
- Sponsor
- AnnJi Pharmaceutical Co., Ltd.