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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: E6011 Matching Placebo; Drug: E6011

Study type: Interventional

Funder types: Industry

Identifiers

NCT01731275

E6011-J081-001

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

E6011

Experimental group

Treatment:

Drug: E6011

E6011 Matching Placebo

Placebo Comparator group

Treatment:

Drug: E6011 Matching Placebo