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To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E6011 | Experimental |
| |
| E6011 Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6011 | Drug | A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | An Adverse Event (AE) is any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. The investigator or sub-investigator reviews all laboratory findings and determines if they constitute an AE. In-patient observation assessments will be performed during 1 week post-dose, followed by the out-patient observation assessments in groups: 0.0006, 0.006, 0.04, 0.2 mg/kg up to the end of Week 8 and in groups: 1, 3, 6, 10 kg/mg) up to the end of Week 24. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Up to 24 Weeks post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Up to 24 Weeks post-dose | |
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Inclusion criteria;
Exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Kiyoshi Oketani | KAN Clinical Development Section, JAPAN/ASIA Clinical Research Product Creation Unit, Eisai Product Creation System | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sagamihara | Kanagawa | Japan |
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| ID | Term |
|---|---|
| C000627635 | quetmolimab |
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| E6011 Matching Placebo | Drug | A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group. |
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| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] |
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). |
| Up to 24 Weeks post-dose |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] | AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | Up to 24 Weeks post-dose |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Up to 24 Weeks post-dose |
| Pharmacokinetic Parameter: Volume of Distribution (Vd) | Up to 24 Weeks post-dose |
| Pharmacokinetic Parameter: Clearance (CL) | Up to 24 Weeks post-dose |