The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
24
EA Pharma Trial Site
Higashi, Fukuoka, Japan
Serum Concentrations of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Change from Baseline in Serum Concentration of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC 0-t) of E3112
AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC∞) of E3112
AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
Clearance (CL) of E3112
CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Hematology parameter value
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Urine Value
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Vital Signs
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Physical Findings
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Ophthalmological Findings
Time frame: Day 1 to Day 43
Percentage of Participants with Serum Anti-E3112 Antibodies
Time frame: Day 1 to Day 43