EA Pharma Trial Site
Toshima City, Tokyo, Japan
NCT Number: NCT03014895
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.
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Notify Me20 year–44 year
Male
Interventional
Early Phase 1
Toshima City, Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Main Inclusion Criteria:
Exclusion criteria
Main Exclusion Criteria:
Intravenous infusion
Intravenous infusion
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.
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.
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.
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.
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.
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.
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.
Time frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Time frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Time frame: Days 1 to 28
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
Time frame: Baseline; Days 1 to 28
Clinical significance will be determined by the investigator.
EA Pharma Co., Ltd.
Industry
A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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