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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Lecanemab; Drug: Lecanemab

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: Lecanemab 720 mg; Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.	Drug: Lecanemab; Lecanemab will be administered subcutaneously using a vial and syringe.; Other Names: BAN2401; Drug: Lecanemab; Lecanemab will be administered subcutaneously using AI.; Other Names: BAN2401
Experimental: Treatment B: Lecanemab 720 mg; Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.	Drug: Lecanemab; Lecanemab will be administered subcutaneously using a vial and syringe.; Other Names: BAN2401; Drug: Lecanemab; Lecanemab will be administered subcutaneously using AI.; Other Names: BAN2401

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	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.	Up to Day 50
Number of Participants With Abnormal Laboratory Values	Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.	Baseline up to Day 22
Number of Participants With Abnormal Vital Signs Values	Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight.	Baseline up to Day 50
Number of Participants With Anti-drug Antibodies (ADAs)	ADAs will be measured using validated electrochemiluminescent immunoassay methods.	Baseline up to Day 50
Number of Participants With Neutralizing Antibodies (NAbs)	NAbs will be measured using validated electrochemiluminescent immunoassay methods.	Baseline up to Day 50

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: BAN2401; Lecanemab
• Other Study ID Numbers: BAN2401-A001-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No