A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

November 12, 2018 updated by: EA Pharma Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects

The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Toshima, Tokyo, Japan
        • EA Pharma Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Main Inclusion Criteria:

  • Non-smoking, Japanese, male participants, ≥20 and <45 years old at the time of obtaining informed consent
  • Have a Body Mass Index (BMI) ≥18.5 and <25.0 kilograms per meters squared (kg/m^2) at Screening
  • Able to provide written informed consent of their free will
  • Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them

Exclusion Criteria:

Main Exclusion Criteria:

  • Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
  • Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
  • Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
  • Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
  • Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
  • Receipt of vaccination within 4 weeks prior to dosing
  • History of drug or alcohol dependency or abuse prior to Screening
  • Intake of caffeinated beverages or food within 72 hours prior to dosing
  • Use of prescription drugs within 4 weeks prior to dosing
  • Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
  • Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
  • Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Cohort 1: Placebo
Intravenous placebo infusion
Drug: Placebo
Intravenous infusion
Experimental: Cohort 1: E3112
Intravenous E3112 infusion
Drug: E3112
Intravenous infusion
Placebo Comparator: Cohort 2: Placebo
Intravenous placebo infusion
Drug: Placebo
Intravenous infusion
Experimental: Cohort 2: E3112
Intravenous E3112 infusion
Drug: E3112
Intravenous infusion
Placebo Comparator: Cohort 3: Placebo
Intravenous placebo infusion
Drug: Placebo
Intravenous infusion
Experimental: Cohort 3: E3112
Intravenous E3112 infusion
Drug: E3112
Intravenous infusion
Placebo Comparator: Cohort 4: Placebo
Intravenous placebo infusion
Drug: Placebo
Intravenous infusion
Experimental: Cohort 4: E3112
Intravenous E3112 infusion
Drug: E3112
Intravenous infusion
Placebo Comparator: Cohort 5: Placebo
Intravenous placebo infusion
Drug: Placebo
Intravenous infusion
Experimental: Cohort 5: E3112
Intravenous E3112 infusion
Drug: E3112
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax) of E3112
Time Frame: Days 1 to 4, 8, 14, and 28
Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Days 1 to 4, 8, 14, and 28
Time to peak concentration (Tmax) of E3112
Time Frame: Days 1 to 4, 8, 14, and 28
Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Days 1 to 4, 8, 14, and 28
Area under the curve (AUC)
Time Frame: Days 1 to 4, 8, 14, and 28
AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.
Days 1 to 4, 8, 14, and 28
Half-life of elimination (t1/2) of E3112
Time Frame: Days 1 to 4, 8, 14, and 28
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Days 1 to 4, 8, 14, and 28
Clearance of E3112
Time Frame: Days 1 to 4, 8, 14, and 28
Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Days 1 to 4, 8, 14, and 28
Volume of distribution (Vd) of E3112
Time Frame: Days 1 to 4, 8, 14, and 28
Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
Days 1 to 4, 8, 14, and 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with any serious adverse event and any non-serious adverse event
Time Frame: Days 1 to 28
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Days 1 to 28
Number of participants with an abnormal, clinically significant hematology parameter value
Time Frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value
Time Frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Days 1 to 28
Number of participants with an abnormal, clinically significant urine value
Time Frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement
Time Frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
Time Frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant physical examination measurement
Time Frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
Baseline; Days 1 to 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EA Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E3112/CP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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