Clinical trial NCT01731275: A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)
Official title: A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Healthy volunteers
immunogenicity
anti-E6011 antibody
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to Week 24
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 24 Weeks post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 24 Weeks post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: Up to 24 Weeks post-dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]
timeFrame: Up to 24 Weeks post-dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Up to 24 Weeks post-dose
measure: Pharmacokinetic Parameter: Volume of Distribution (Vd)
timeFrame: Up to 24 Weeks post-dose
measure: Pharmacokinetic Parameter: Clearance (CL)
timeFrame: Up to 24 Weeks post-dose
Other outcomes:
Locations:
city: Sagamihara
country: Japan
state: Kanagawa
Study officials:
affiliation: KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System
name: Kiyoshi Oketani
role: STUDY_DIRECTOR
References: