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Monoclonal Antibodies
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
Phase 1
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 50
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if lecanemab works the same way when given through a vial or an auto-injector in healthy participants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 50
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 50
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants With Abnormal Laboratory Values
Number of Participants With Abnormal Vital Signs Values
Number of Participants With Anti-drug Antibodies (ADAs)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment B: Lecanemab 720 mgExperimental Treatment1 Intervention
Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.
Group II: Treatment A: Lecanemab 720 mgExperimental Treatment1 Intervention
Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lecanemab
2020
Completed Phase 3
~3530
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
521 Previous Clinical Trials
159,638 Total Patients Enrolled