Anaheim Clinical Trials
Anaheim, California, 92801, United States
NCT Number: NCT05045716
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be included in this study:
Exclusion criteria
Participants who meet any of the following criteria will be excluded from this study:
NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.
Lecanemab IV infusion.
Other names: BAN2401
Time frame: Days 0-50
Time frame: 0-72 hours
Time frame: Days 0-50
Time frame: 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.
Time frame: Days 0-50
Time frame: Days 0-50
Time frame: Days 0-50
Time frame: Baseline up to Day 50
Time frame: Baseline up to Day 22
Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.
Time frame: Baseline up to Day 50
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
Time frame: Baseline Up to Day 50
ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods.
Time frame: Baseline up to Day 50
NAb will be measured using validated ECL methods.
Eisai Inc.
Industry
An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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