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The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lecanemab 10 mg/kg | Experimental | Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1. |
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| Lecanemab 700 mg | Experimental | Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lecanemab | Drug | Lecanemab IV infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab | Days 0-50 | |
| AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 Hours Post End of Intravenous (IV) Infusion or SC Administration for Lecanemab | 0-72 hours | |
| AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab | Days 0-50 | |
| F: Absolute Bioavailability of SC Formulation for Lecanemab | Absolute bioavailability (F) = [AUC(0-inf) SC*Dose (IV)]/[AUC(0-inf) IV*Dose (SC)]. IV dose will be based on total dose (mg) infused. | Days 0-50 |
| Cmax: Maximum Observed Serum Concentration for Lecanemab | Days 0-50 | |
| Tmax: Time to Reach Maximum Serum Concentration for Lecanemab | Days 0-50 | |
| T1/2: Terminal Elimination Half-life for Lecanemab | Days 0-50 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to Day 50 | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis. |
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Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | 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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| ID | Term |
|---|---|
| C000612089 | lecanemab |
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| Lecanemab | Drug | Lecanemab SC injection. |
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| Baseline up to Day 22 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | Vital signs parameters will include diastolic and systolic blood pressure (BP), pulse, respiratory rate, body temperature and body weight. | Baseline up to Day 50 |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | Baseline up to Day 50 |
| Number of Participants With Positive and Negative Anti-drug Antibody (ADA) for Lecanemab | ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods. | Baseline Up to Day 50 |
| Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab | NAb will be measured using validated ECL methods. | Baseline up to Day 50 |