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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Anaheim Clinical Trials
Anaheim, California, United States
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
Time frame: 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
Time frame: 0-72 hours
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
Time frame: 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.
Time frame: Days 0-50
Cmax: Maximum Observed Serum Concentration for Lecanemab
Time frame: Days 0-50
Tmax: Time to Reach Maximum Serum Concentration for Lecanemab
Time frame: Days 0-50
T1/2: Terminal Elimination Half-life for Lecanemab
Time frame: Days 0-50
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
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Time frame: 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.
Time frame: Baseline up to Day 50
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: 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.
Time frame: Baseline Up to Day 50
Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab
NAb will be measured using validated ECL methods.
Time frame: Baseline up to Day 50