A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)

A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.

Inclusion criteria;

1. Non-smoking Japanese male subjects aged >= 20 to less than 45 years
2. BMI at screening is >= 18.5 kg/m2 to less than 25.0 kg/m^2
3. Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period.

Exclusion criteria;

1. Has been treated with biologic products (except for immunoglobulin preparation)
2. Have received immunoglobulin or blood preparation within 6 months before the study drug administration
3. Received inoculation within 4 weeks before the study drug administration
4. Has a history of autoimmune disease or immunodeficiency
5. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
6. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterate
7. With gross hematuria, occult bleeding in urine (>=1+) and urine protein (>=1+) , or either of (>=2+) at screening
8. Has a clinically significant vasculitis (e.g., multiple mononeuropathy)
9. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test
10. Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at screening
11. Known to be positive for QuantiFERON-TB Gold Test
12. Treated with ethical drug(s) within 4 weeks before the study drug administration (except for disinfectants, eye drops)
13. Treated with non-prescription drug(s) within 2 weeks before the study drug administration (except for disinfectants, eye drops)
14. Has participated in another clinical trial and received an investigational drug or device within 6 months before the study drug administration
15. Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study drug administration.