A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Parallel-Group, Randomized Study to Demonstrate the Bioequivalence of the Subcutaneous Formulation of Lecanemab Supplied in Vials and a Single-Use Auto-Injector

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lecanemab
* Drug: Lecanemab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing Body Mass Index >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening Exclusion Criteria: Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent Prior exposure to lecanemab, or any other anti-amyloid therapies Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body [mAb]) treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Lecanemab 720 mg<br>Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1. | Drug: Lecanemab<br>* Lecanemab will be administered subcutaneously using a vial and syringe.<br>* Other names: BAN2401;|
| Experimental: Treatment B: Lecanemab 720 mg<br>Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1. | Drug: Lecanemab<br>* Lecanemab will be administered subcutaneously using AI.<br>* Other names: BAN2401;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BAN2401, Lecanemab