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

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: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: E3112

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax) of E3112	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	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)	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Number of participants with any serious adverse event and any non-serious adverse event	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	Clinical significance will be determined by the investigator.	Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value	Clinical significance will be determined by the investigator.	Days 1 to 28
Number of participants with an abnormal, clinically significant urine value	Clinical significance will be determined by the investigator.	Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement	Clinical significance will be determined by the investigator.	Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement	Clinical significance will be determined by the investigator.	Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant physical examination measurement	Clinical significance will be determined by the investigator.	Baseline; Days 1 to 28

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): June 12, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Japanese; E3112
• Other Study ID 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