Healthy volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : E6011
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : 0.0006, 0.006, 0.
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Non-smoking Japanese males aged between 20 and 44 years old, 2. BMI at screening is between 18.5 kg/m2 and <25.0 kg/m2, 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
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. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis, 4. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis abliterate, 5. With gross hematuria, occult bleeding in urine (greater than or equal to 1+) and urine protein (greater than or equal to 1+), or either of greater than or equal to 2+ at screnning, 6.Has a clinically significant vasculitis (e.g., multiple mononeuropathy), 7. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (NBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test, 8. Known to be positive for QuantiFERON-TB Gold Test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | — |
Outcome results
None listed