Healthy Volunteers
Conditions
Keywords
BAN2401, Lecanemab
Brief summary
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.
Interventions
DRUGLecanemab
Lecanemab will be administered subcutaneously using a vial and syringe.
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
1. 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 2. Body Mass Index \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening
Exclusion criteria
1. 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 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 participants who have a congenital abnormality in metabolism 3. 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 4. Prior exposure to lecanemab, or any other anti-amyloid therapies 5. Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body \[mAb\]) treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 50 | 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. |
| Number of Participants With Abnormal Laboratory Values | Baseline up to Day 22 | Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis. |
| Number of Participants With Abnormal Vital Signs Values | Baseline up to Day 50 | Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight. |
| Number of Participants With Anti-drug Antibodies (ADAs) | Baseline up to Day 50 | ADAs will be measured using validated electrochemiluminescent immunoassay methods. |
| Number of Participants With Neutralizing Antibodies (NAbs) | Baseline up to Day 50 | NAbs will be measured using validated electrochemiluminescent immunoassay methods. |
Countries
United States
Outcome results
None listed