Healthy Male VolunteersPhase 1NCT01731275
A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)
A Phase 1 study testing E6011 in people with Healthy Male Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- E6011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects
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
- Being tested
- E6011, E6011 Matching Placebo
- Keywords
- Healthy volunteers, immunogenicity, anti-E6011 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011Drug
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 Matching PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| E6011 | Experimental | Not described Receives: Drug: E6011 |
| E6011 Matching Placebo | Placebo comparator | Not described Receives: Drug: E6011 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 24
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 24 Weeks post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
Measured: Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Measured: Up to 24 Weeks post-dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Up to 24 Weeks post-dose
Pharmacokinetic Parameter: Volume of Distribution (Vd)
Measured: Up to 24 Weeks post-dose
Pharmacokinetic Parameter: Clearance (CL)
Measured: Up to 24 Weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiyoshi Oketani, Study director, KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731275
- Sponsor's protocol ID
- E6011-J081-001
- Status last verified
- Feb 2014
- First submitted
- 31 Aug 2012
- Last updated
- 14 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01731275
- Acronym / sponsor ID
- E6011-J081-001
- Conditions
- Healthy Male Volunteers
- Keywords
- Healthy volunteers, immunogenicity, anti-E6011 antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E6011 | Experimental | Drug: E6011 |
| E6011 Matching Placebo | Placebo comparator | Drug: E6011 Matching Placebo |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E6011A 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. | Drug | E6011 |
| E6011 Matching PlaceboA 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. | Drug | E6011 Matching Placebo |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to Week 24
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.
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 24 Weeks post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: Up to 24 Weeks post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)]
Time frame: Up to 24 Weeks post-dose
Plasma Decay Half-Life (t1/2)
Time frame: Up to 24 Weeks post-dose
Pharmacokinetic Parameter: Volume of Distribution (Vd)
Time frame: Up to 24 Weeks post-dose
Pharmacokinetic Parameter: Clearance (CL)
Time frame: Up to 24 Weeks post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyoshi Oketani study director
KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E6011 in people with Healthy Male Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.