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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
160
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: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
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.
Time frame: Up to Day 50
Number of Participants With Abnormal Laboratory Values
Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.
Time frame: Baseline up to Day 22
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Baseline up to Day 50
Number of Participants With Anti-drug Antibodies (ADAs)
ADAs will be measured using validated electrochemiluminescent immunoassay methods.
Time frame: Baseline up to Day 50
Number of Participants With Neutralizing Antibodies (NAbs)
NAbs will be measured using validated electrochemiluminescent immunoassay methods.
Time frame: Baseline up to Day 50