A Study of Subcutaneous Lecanemab in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects

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: Participants must meet all of the following criteria to be included in this study: Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years old at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing. Japanese participants (age >=20 years) must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan. Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at screening. Exclusion Criteria: Participants who meet any of the following criteria will be excluded from this study: Clinically significant illness that requires medical treatment within 8 weeks 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 subjects who have a congenital abnormality in metabolism Exposure within the last 14 days before dosing to an individual with confirmed or probable corona virus disease-2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing 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 Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.

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: Lecanemab 10 mg/kg<br>Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1. | Drug: Lecanemab<br>* Lecanemab IV infusion.<br>* Other names: BAN2401;|
| Experimental: Lecanemab 700 mg<br>Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1. | Drug: Lecanemab<br>* Lecanemab SC injection.<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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

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