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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Group A: E3112 + Placebo | Experimental | E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
|
| Cohort 1 Group B: Placebo + E3112 | Experimental | Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
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| Cohort 2 Group A: E3112 + Placebo | Experimental | E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
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| Cohort 2 Group B: Placebo + E3112 | Experimental | Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
|
| Cohort 3 Group A: E3112 + Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E3112 | Drug | Intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of E3112 | Day 1: 0-24 hours; Day 8: 0-24 hours | |
| Change from Baseline in Serum Concentration of E3112 | 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. | 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. | 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. | 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. | 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. | Day 1: 0-24 hours; Day 8: 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 to Day 43 | |
| Number of Participants with an Abnormal, Clinically Significant Hematology parameter value | Day 1 to Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EA Pharma Trial Site | Higashi | Fukuoka | Japan |
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E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
|
| Cohort 3 Group B: Placebo + E3112 | Experimental | Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
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| Cohort 4 Group A: E3112 + Placebo | Experimental | E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
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| Cohort 4 Group B: Placebo + E3112 | Experimental | Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. |
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| Placebo | Other | Intravenous infusion. |
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| Clearance (CL) of E3112 | CL is defined as the rate of drug elimination divided by the plasma concentration of the drug. | 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. | Day 1: 0-24 hours; Day 8: 0-24 hours |
| Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value | Day 1 to Day 43 |
| Number of Participants with an Abnormal, Clinically Significant Urine Value | Day 1 to Day 43 |
| Number of Participants with Clinically Significant Change in Vital Signs | Day 1 to Day 43 |
| Number of Participants with Clinically Significant Change in Electrocardiogram (ECG) | Day 1 to Day 43 |
| Number of Participants with Clinically Significant Change in Physical Findings | Day 1 to Day 43 |
| Number of Participants with Clinically Significant Change in Ophthalmological Findings | Day 1 to Day 43 |
| Percentage of Participants with Serum Anti-E3112 Antibodies | Day 1 to Day 43 |