An ascending single dose, randomised, double-blind, placebo-controlled phase 1 study of the tolerability, pharmacokinetics and pharmacodynamics of AJM300 in healthy adult males in the fasting and fed states
- Conditions
- Healthy adult Subjects
- Registration Number
- JPRN-jRCT1080224924
- Lead Sponsor
- EA Pharma Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 62
Main inclusion criteria
- Able to provide written informed consent.
- Male subjects aged>=18 to < 55 years and in good health as determined at screening.
- BMI within 18-28 kg/m2.
- Able to communicate well with the Investigator and comply with the study requirements.
Main exclusion criteria
- Any medical or surgical condition which might significantly alter drug absorption,distribution metabolism of excretion.
- Concurrent gastrointestinal disease.
- History of drug allergy.
- History of drug or alcohol abuse.
- Current smokers or cessation of smoking within 3 months of dosing.
- Use of any prescription medication within 28 days prior to dosing and over-the counter medication and vitamins within 3 days prior to dosing.
- Participation in any clinical study within 3 months prior to dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>- Physical examination results<br>- Vital signs<br>- ECGs<br>- Safety laboratory test results<br>- CRP<br>- Adverse events
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>AJM300 and metabolites