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

NCT ID: NCT01731275

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

Brief Summary

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

Conditions

Healthy Male Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

E6011 Matching Placebo

Group Type: PLACEBO_COMPARATOR

E6011 Matching Placebo

Intervention Type: DRUG

A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.

E6011

Group Type: EXPERIMENTAL

E6011

Intervention Type: DRUG

A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.

Interventions

E6011

A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.

Intervention Type: DRUG

E6011 Matching Placebo

A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiyoshi Oketani

Role: STUDY_DIRECTOR

KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System

Locations

Sagamihara, Kanagawa, Japan

Countries

Japan

Other Identifiers

E6011-J081-001

Identifier Type: -

Identifier Source: org_study_id