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The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Lecanemab 720 mg | Experimental | Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1. |
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| Treatment B: Lecanemab 720 mg | Experimental | Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lecanemab | Drug | Lecanemab will be administered subcutaneously using a vial and syringe. |
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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 | 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose | |
| AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab | 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose | |
| Cmax: Maximum Observed Serum Concentration for Lecanemab | 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose | |
| Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab | 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose | |
| t1/2: Terminal Elimination Phase Half-life for Lecanemab | 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE is defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (baseline) or reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. |
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Inclusion Criteria:
Exclusion Criteria:
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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 will be administered subcutaneously using AI. |
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| Up to Day 50 |
| Number of Participants With Abnormal Laboratory Values | Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis. | Baseline up to Day 22 |
| Number of Participants With Abnormal Vital Signs Values | Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight. | Baseline up to Day 50 |
| Number of Participants With Anti-drug Antibodies (ADAs) | ADAs will be measured using validated electrochemiluminescent immunoassay methods. | Baseline up to Day 50 |
| Number of Participants With Neutralizing Antibodies (NAbs) | NAbs will be measured using validated electrochemiluminescent immunoassay methods. | Baseline up to Day 50 |