> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-demonstrate-the-bioequivalence-of-lecanemab-af19c653-f2a7-4c70-821c-5cebe9185aac > Record changed: 2026-10-13 # A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants NCT05533801 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Lead sponsor Eisai Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Start date 2022-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Short title** A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Official title** An Open-Label, Parallel-Group, Randomized Study to Demonstrate the Bioequivalence of the Subcutaneous Formulation of Lecanemab Supplied in Vials and a Single-Use Auto-Injector Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Dates **Completion date** 2023-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **First posted** 2022-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Registry last updated** 2023-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Primary completion date** 2023-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Start date** 2022-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Lead sponsor** Eisai Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Identifiers **Registry ID** NCT05533801 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **ClinicalTrials.gov ID** NCT05533801 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Outcomes ### Primary outcomes 1. AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab Timeframe: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose 2. AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab Timeframe: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose 3. Cmax: Maximum Observed Serum Concentration for Lecanemab Timeframe: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose 4. Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab Timeframe: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose 5. t1/2: Terminal Elimination Phase Half-life for Lecanemab Timeframe: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose ### Secondary outcomes 1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to Day 50 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. 2. Number of Participants With Abnormal Laboratory Values Timeframe: Baseline up to Day 22 Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis. 3. Number of Participants With Abnormal Vital Signs Values Timeframe: Baseline up to Day 50 Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight. 4. Number of Participants With Anti-drug Antibodies (ADAs) Timeframe: Baseline up to Day 50 ADAs will be measured using validated electrochemiluminescent immunoassay methods. 5. Number of Participants With Neutralizing Antibodies (NAbs) Timeframe: Baseline up to Day 50 NAbs will be measured using validated electrochemiluminescent immunoassay methods. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria 1. 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 2. Body Mass Index >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening ### Exclusion criteria 1. 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 2. 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 3. 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 4. Prior exposure to lecanemab, or any other anti-amyloid therapies 5. Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body \[mAb\]) treatment Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Sites - Anaheim Clinical TrialsAnaheim, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05533801) ## Related records ### Drugs (1) - [Lecanemab](https://trialight.com/data/asset/lecanemab-49c04892-5218-40d4-bf54-c66ea2ad6d64.md) ### Lead sponsors (1) - [Eisai Inc.](https://trialight.com/data/company/eisai-inc-f92b3ede-0a32-4c7d-80d0-1dc62ba1ee01.md) ### Targets (1) - [APP](https://trialight.com/data/target/app-66e1e975-c08a-5f7c-afdf-454125fc2bc4.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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