A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lecanemab

• Registration Number: NCT05533801
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-09-06
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Primary Completion: 2023-01-06
• Study Completion: 2023-01-06
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A: Lecanemab 720 mg	Lecanemab	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 B: Lecanemab 720 mg	Lecanemab	Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.

Primary Outcome Measures

Name	Time	Method
Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab	0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Cmax: Maximum Observed Serum Concentration for Lecanemab	0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab	0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab	0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
t1/2: Terminal Elimination Phase Half-life for Lecanemab	0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values	Baseline up to Day 22	Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.
Number of Participants With Abnormal Vital Signs Values	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	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.
Number of Participants With Anti-drug Antibodies (ADAs)	Baseline up to Day 50	ADAs will be measured using validated electrochemiluminescent immunoassay methods.
Number of Participants With Neutralizing Antibodies (NAbs)	Baseline up to Day 50	NAbs will be measured using validated electrochemiluminescent immunoassay methods.

Trial Locations

Locations (1)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States