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

ArmDescriptionAssigned Intervention
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).

Recruiting Locations

AnnJi Investigational Site
Los Alamitos, California 90720
Contact:
CNS Outreach
844-424-9494
cns.outreach@cenexel.com

More Details

Status
Recruiting
Sponsor
AnnJi Pharmaceutical Co., Ltd.

Study Contact

Andy Chen, PhD
+886223655677
andy.chen@ajpharm.com