Healthy Adult Subjects
Conditions
Interventions
investigational material(s)
Generic name etc : E3112
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : single dose
cont
Sponsors
EA Pharma Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria 1. Non-smoking, Japanese male subject, age >=20 and =18.5 and <25.0 kg/m2 at Screening 3. Provide written informed consent of their free will 4. Subject who was given full explanation of all the requirements of the protocol, and are willing and able to comply with them
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria 1. Subject and his partner do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity 2. Subject who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing 3. Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing 4. Any history of surgical treatment that may affect PK profiles of study drug at Screening 5. Any suspected clinically abnormal symptom or organ impairment that requires medical treatment at Screening or Baseline 6. Receipt of vaccination within 4 weeks prior to dosing 7. History of drug or alcohol dependency or abuse 8. Intake of caffeinated beverages or food within 72 hours prior to dosing 9. Use of prescription drugs within 4 weeks prior to dosing 10. Intake of over-the-counter [OTC] medications within 2 weeks prior to dosing 11. Subject who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing 12. Subject who underwent blood transfusion within 12 weeks, or who donated 400 mL or more of whole blood within 12 weeks or 200 mL or more of whole blood within 4 weeks, or who made a component donation within 2 weeks prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Pharmacokinetic Assessments - Safety Endpoints - Serum concentrations of E3112 - Monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and ECGs; and performance of physical examinations | — |
Outcome results
None listed