Healthy adult Subjects
Conditions
Sponsors
EA Pharma Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Physical examination results - Vital signs - ECGs - Safety laboratory test results - CRP - Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics AJM300 and metabolites | — |
Countries
Europe
Outcome results
None listed