Actively Recruiting
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
Led by AnnJi Pharmaceutical Co., Ltd. · Updated on 2026-04-24
26
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, non-smokers (no tobacco or nicotine use within 3 months prior to screening), aged 18 to 55 years
- Body mass index between 18.5 and 30.0 kg/m2 and body weight at least 50.0 kg
- Normal renal function at screening
- Healthy with no clinically significant illness or surgery within 4 weeks before study drug administration
- No significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- Participants must be either Japanese or White
- Able to understand study procedures and provide signed informed consent
You will not qualify if you...
- Any clinically significant abnormal finding on physical examination
- Clinically significant abnormal laboratory tests or positive serology for hepatitis B, hepatitis C, or HIV 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 abnormal vital signs at screening
- History of drug or alcohol abuse
- Current or past smoking or use of nicotine-containing products
- Major surgery within 3 months before first study drug administration
- History of serious infections, medical/surgical procedures, trauma, or current infection
- Use of disallowed medications as specified in the protocol
- Presence of orthodontic braces, retention wires, or any mouth or tongue condition interfering with drug dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AnnJi Investigational Site
Los Alamitos, California, United States, 90720
Actively Recruiting
Research Team
A
Andy Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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