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

NCT01731275 | Completed Phase 1

• 1 other identifier: E6011-J081-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers; immunogenicity; anti-E6011 antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24.

  Up to Week 24

Secondary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax)

  Up to 24 Weeks post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Up to 24 Weeks post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  Up to 24 Weeks post-dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]

  Up to 24 Weeks post-dose

• Plasma Decay Half-Life (t1/2)

  Up to 24 Weeks post-dose

Study Arms (2)

E6011

EXPERIMENTAL

Drug: E6011

E6011 Matching Placebo

PLACEBO COMPARATOR

Drug: E6011 Matching Placebo

Interventions

E6011 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.

E6011

E6011 Matching Placebo 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 Matching Placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Has been treated with biologic products (except for immunoglobulin preparation)
• Have received immunoglobulin or blood preparation within 6 months before the study drug administration
• Received inoculation within 4 weeks before the study drug administration
• Has a history of autoimmune disease or immunodeficiency
• Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
• Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterate
• With gross hematuria, occult bleeding in urine (\>=1+) and urine protein (\>=1+) , or either of (\>=2+) at screening
• Has a clinically significant vasculitis (e.g., multiple mononeuropathy)
• 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
• Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at screening
• Known to be positive for QuantiFERON-TB Gold Test
• Treated with ethical drug(s) within 4 weeks before the study drug administration (except for disinfectants, eye drops)
• Treated with non-prescription drug(s) within 2 weeks before the study drug administration (except for disinfectants, eye drops)
• Has participated in another clinical trial and received an investigational drug or device within 6 months before the study drug administration
• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sagamihara, Kanagawa, Japan

Location

MeSH Terms

Interventions

quetmolimab

Study Officials

• Kiyoshi Oketani

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: November 21, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

JP (1)