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Treatment A: Lecanemab 720 mg for Healthy Subjects
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
Is the drug Lecanemab 720 mg endorsed by the FDA?
"With limited clinical data available to assess the safety and efficacy of Treatment A: Lecanemab 720 mg, it is estimated to receive a score of 1."
Is this research actively looking for participants?
"Clinicaltrials.gov displays that, although initially posted on September 6th 2022 and last amended November 22nd 2022, this medical trial is not presently enlisting participants. Nonetheless, there are 841 other studies actively recruiting patients at the present time."
Can individuals aged 50 or more take part in this trial?
"Eligibility for this trial stipulates that patients must be between the ages of 18 and 65. However, there are 50 trials specifically targeting those under 18 years old as well as 373 studies aimed at individuals over the age of 65."
What prerequisites must one fulfill in order to qualify for participation in this clinical trial?
"To qualify for this trial, potential participants should be in good health and between the ages of 18 to 65. A total of 160 people are being accepted into the study."
What objectives are researchers hoping to accomplish from this research endeavor?
"According to the trial sponsor, Eisai Inc., the primary outcome measured over a 0 (Pre-dose), 4, 8, 24, 48, 72 etc. post-dose period is AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab. Additionally, this study will assess secondary metrics such as Abnormal Vital Signs Values (BP/Pulse Rate/Respiratory Rate/Body Temp./Weight), Abnormal Laboratory Parameters (Hematology/Chemistry/Urinalysis) and Anti-drug Antib"
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