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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
29
EA Pharma Trial Site
Toshima City, Tokyo, Japan
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 1 to 4, 8, 14, and 28
Number of participants with any serious adverse event and any non-serious adverse event
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant hematology parameter value
Clinical significance will be determined by the investigator.
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value
Clinical significance will be determined by the investigator.
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant urine value
Clinical significance will be determined by the investigator.
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant physical examination measurement
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28