A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
Sponsor study identifier
interventional
29
1 country
1
Study Start
January 25, 2017
Actual (reported)Primary Completion
June 12, 2017
Actual (reported)Study Completion
November 22, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2017
Actual (reported)January 9, 2017
Actual (reported)January 25, 2017
Actual (reported)June 12, 2017
Actual (reported)November 22, 2017
Actual (reported)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.
Number of participants with any serious adverse event and any non-serious adverse event
Days 1 to 28
Number of participants with an abnormal, clinically significant hematology parameter value
Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value
Days 1 to 28
Number of participants with an abnormal, clinically significant urine value
Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement
Baseline; Days 1 to 28
Intravenous placebo infusion
Intravenous E3112 infusion
Intravenous placebo infusion
Intravenous infusion
EA Pharma Trial Site
Toshima City, Tokyo, Japan
29 participants (actual enrollment reported by the registry).
First Submitted
January 6, 2017
First Posted
January 9, 2017
Study Start
January 25, 2017
Actual (reported)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
Intravenous E3112 infusion
Intravenous placebo infusion
Intravenous E3112 infusion
Intravenous placebo infusion
Intravenous E3112 infusion
Intravenous placebo infusion
Intravenous E3112 infusion
Intravenous infusion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 12, 2017
Actual (reported)Study Completion
November 22, 2017
Actual (reported)Last Updated
November 14, 2018
Record last verified: 2018-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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