A Study of Subcutaneous Lecanemab in Healthy Participants

An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects

The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 60
• 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: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

1. Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years old at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
2. Japanese participants (age >=20 years) must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan.
3. Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at screening.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Clinically significant illness that requires medical treatment within 8 weeks 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 subjects who have a congenital abnormality in metabolism
3. Exposure within the last 14 days before dosing to an individual with confirmed or probable corona virus disease-2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection
4. Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing
5. 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
6. Prior exposure to lecanemab
7. Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment

NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.

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: Lecanemab 10 mg/kg; Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1.	Drug: Lecanemab; Lecanemab IV infusion.; Other Names: BAN2401; Drug: Lecanemab; Lecanemab SC injection.; Other Names: BAN2401
Experimental: Lecanemab 700 mg; Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1.	Drug: Lecanemab; Lecanemab IV infusion.; Other Names: BAN2401; Drug: Lecanemab; Lecanemab SC injection.; Other Names: BAN2401

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab		Days 0-50
AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 Hours Post End of Intravenous (IV) Infusion or SC Administration for Lecanemab		0-72 hours
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab		Days 0-50
F: Absolute Bioavailability of SC Formulation for Lecanemab	Absolute bioavailability (F) = [AUC(0-inf) SC*Dose (IV)]/[AUC(0-inf) IV*Dose (SC)]. IV dose will be based on total dose (mg) infused.	Days 0-50
Cmax: Maximum Observed Serum Concentration for Lecanemab		Days 0-50
Tmax: Time to Reach Maximum Serum Concentration for Lecanemab		Days 0-50
T1/2: Terminal Elimination Half-life for Lecanemab		Days 0-50

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 50
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters	Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.	Baseline up to Day 22
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values	Vital signs parameters will include diastolic and systolic blood pressure (BP), pulse, respiratory rate, body temperature and body weight.	Baseline up to Day 50
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings		Baseline up to Day 50
Number of Participants With Positive and Negative Anti-drug Antibody (ADA) for Lecanemab	ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods.	Baseline Up to Day 50
Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab	NAb will be measured using validated ECL methods.	Baseline up to Day 50

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Subcutaneous; Bioavailability; Lecanemab
• Other Study ID Numbers: BAN2401-A001-004

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