Healthy Volunteers
Conditions
Keywords
Lecanemab, Bioavailability, Subcutaneous
Brief summary
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.
Interventions
DRUGLecanemab
Lecanemab IV infusion.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria to be included in this study: 1. 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. 2. 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. 3. 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: 1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing. 2. 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 3. 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 4. Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing 5. 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 6. Prior exposure to lecanemab 7. Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment NOTE-Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tmax: Time to Reach Maximum Serum Concentration for Lecanemab | Days 0-50 | — |
| T1/2: Terminal Elimination Half-life for Lecanemab | Days 0-50 | — |
| F: Absolute Bioavailability of SC Formulation for Lecanemab | Days 0-50 | 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. |
| Cmax: Maximum Observed Serum Concentration for Lecanemab | Days 0-50 | — |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab | Baseline up to Day 50 | NAb will be measured using validated ECL methods. |
| 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 | Baseline up to Day 22 | Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values | Baseline up to Day 50 | Vital signs parameters will include diastolic and systolic blood pressure (BP), pulse, respiratory rate, body temperature and body weight. |
| 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 | Baseline Up to Day 50 | ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods. |
Countries
United States
Outcome results
None listed