A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05533801
- Run by
- Eisai Inc.
- People needed
- 160
- Starts
- 2022-09-06
- Expected to finish
- 2023-01-06
- Last updated by the study team
- 2023-01-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
- Body Mass Index >=18 and less than (<) 30 kilogram per square meter (kg/m\^2) at Screening
You may not qualify if…
- Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent
- Prior exposure to lecanemab, or any other anti-amyloid therapies
- Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body [mAb]) treatment
Where it is running
- Anaheim Clinical Trials — Anaheim, California, United States
Full record on ClinicalTrials.gov
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