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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: Placebo
* Drug: E3112


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1: Placebo<br>Intravenous placebo infusion | Drug: Placebo<br>* Intravenous infusion<br>|
| Experimental: Cohort 1: E3112<br>Intravenous E3112 infusion | Drug: E3112<br>* Intravenous infusion<br>|
| Placebo Comparator: Cohort 2: Placebo<br>Intravenous placebo infusion | Drug: Placebo<br>* Intravenous infusion<br>|
| Experimental: Cohort 2: E3112<br>Intravenous E3112 infusion | Drug: E3112<br>* Intravenous infusion<br>|
| Placebo Comparator: Cohort 3: Placebo<br>Intravenous placebo infusion | Drug: Placebo<br>* Intravenous infusion<br>|
| Experimental: Cohort 3: E3112<br>Intravenous E3112 infusion | Drug: E3112<br>* Intravenous infusion<br>|
| Placebo Comparator: Cohort 4: Placebo<br>Intravenous placebo infusion | Drug: Placebo<br>* Intravenous infusion<br>|
| Experimental: Cohort 4: E3112<br>Intravenous E3112 infusion | Drug: E3112<br>* Intravenous infusion<br>|
| Placebo Comparator: Cohort 5: Placebo<br>Intravenous placebo infusion | Drug: Placebo<br>* Intravenous infusion<br>|
| Experimental: Cohort 5: E3112<br>Intravenous E3112 infusion | Drug: E3112<br>* Intravenous infusion<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E3112, Pharmacokinetics, Japanese