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The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohort 1: E2025 Dose 1 or Placebo | Experimental | Participants will receive E2025 Dose 1 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1. |
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| Part A, Cohort 2: E2025 Dose 2 or Placebo | Experimental | Participants will receive E2025 Dose 2 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1. |
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| Part A, Cohort 3: E2025 Dose 3 or Placebo | Experimental | Participants will receive E2025 Dose 3 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1. |
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| Part A, Cohort 4: E2025 Dose 4 or Placebo | Experimental | Participants will receive E2025 Dose 4 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1. |
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| Part B, Cohort 5: E2025 Dose 2 | Experimental | Participants will receive E2025 Dose 2 administered as an IV infusion on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2025 | Drug | E2025 IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Screening up to Day 113 | |
| Number of Participants With Clinically Significant Abnormal Laboratory Values | Screening up to Day 113 | |
| Number of Participants With Clinically Significant Abnormal Vital Signs Values | Screening up to Day 113 | |
| Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings | Screening up to Day 113 | |
| Number of Participants With Clinically Significant Abnormal Physical Examinations Findings | Screening up to Day 113 | |
| Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings | Screening up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Serum Concentration for E2025 | Day 1: 0-24 hours up to Day 113 | |
| Tmax: Time to Reach Maximum Observed Serum Concentration (Cmax) for E2025 | Day 1: 0-24 hours up to Day 113 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| Part B, Cohort 6: E2025 Dose 3 | Experimental | Participants will receive E2025 Dose 3 administered as an IV infusion on Day 1. |
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| Part B Cohort 7: E2025 Dose 4 | Experimental | Participants will receive E2025 Dose 4 administered as an IV infusion on Day 1. |
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| Placebo | Drug | E2025 matched placebo IV infusion. |
|
| AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Last Quantifiable Concentration for E2025 |
| Day 1: 0-24 hours up to Day 113 |
| AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Infinite for E2025 | Day 1: 0-24 hours up to Day 113 |
| AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025 | Day 1: 0-24 hours |
| AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025 | Day 1: 0-72 hours |
| AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025 | Day 1: 0-672 hours |
| t1/2: Terminal Elimination Phase Half-life for E2025 | Day 1: 0-24 hours up to Day 113 |
| CL/F: Apparent Total Clearance for E2025 | Day 1: 0-24 hours up to Day 113 |
| Vss: Volume of Distribution at Steady State for E2025 | Day 1: 0-24 hours up to Day 113 |
| Part A: Cerebrospinal Fluid (CSF) Concentrations for E2025 | Pre-dose; Days 8 and 29 post-dose |
| Part B, CSF Cmax: Maximum Observed CSF Concentration for E2025 | Day 1: 0-24 hours up to Day 99 |
| Part B, CSF Tmax: Time to Reach Maximum Observed CSF Concentration (Cmax) for E2025 | Day 1: 0-24 hours up to Day 99 |
| Part B, CSF AUC(0-24h): Area Under the CSF Concentration-time Curve From Time Zero to 24 hours for E2025 | Day 1: 0-24 hours |
| Part B: Ratio of Cmax in CSF and Cmax in Serum for E2025 | Day 1: 0-24 hours up to Day 99 |
| Part B: Ratio of AUC(0-24h) in CSF and AUC(0-24h) in Serum for E2025 | Day 1: 0-24 hours |
| Serum Concentration of Anti- E2025 Antibodies | Day 1 up to Day 113 |