Healthy Male Volunteers
Conditions
Keywords
E3112, Pharmacokinetics, Japanese
Brief summary
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.
Interventions
DRUGPlacebo
Intravenous infusion
DRUGE3112
Intravenous infusion
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration (Cmax) of E3112 | 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. |
| Time to peak concentration (Tmax) of E3112 | 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. |
| Area under the curve (AUC) | 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. |
| Half-life of elimination (t1/2) of E3112 | 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. |
| Clearance of E3112 | 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. |
| Volume of distribution (Vd) of E3112 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with any serious adverse event and any non-serious adverse event | 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. |
| Number of participants with an abnormal, clinically significant physical examination measurement | Baseline; Days 1 to 28 | Clinical significance will be determined by the investigator. |
| Number of participants with an abnormal, clinically significant hematology parameter value | Days 1 to 28 | Clinical significance will be determined by the investigator. |
| Number of participants with an abnormal, clinically significant blood chemistry parameter value | Days 1 to 28 | Clinical significance will be determined by the investigator. |
| Number of participants with an abnormal, clinically significant urine value | Days 1 to 28 | Clinical significance will be determined by the investigator. |
| Number of participants with an abnormal, clinically significant vital sign measurement | Baseline; Days 1 to 28 | Clinical significance will be determined by the investigator. |
| Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement | Baseline; Days 1 to 28 | Clinical significance will be determined by the investigator. |
Countries
Japan
Outcome results
None listed