A Study of Subcutaneous Lecanemab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lecanemab

• Registration Number: NCT05045716
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

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: 2021-09
• Study Start: 2021-09-07
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lecanemab 10 mg/kg	Lecanemab	Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1.
Lecanemab 700 mg	Lecanemab	Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1.

Primary Outcome Measures

Name	Time	Method
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
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
F: Absolute Bioavailability of SC Formulation for Lecanemab	Days 0-50	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.
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab	Days 0-50

Secondary Outcome Measures

Name	Time	Method
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 Vital Signs Values	Baseline up to Day 50	Vital signs parameters will include diastolic and systolic blood pressure (BP), pulse, respiratory rate, body temperature and body weight.
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	Baseline Up to Day 50	ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods.
Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab	Baseline up to Day 50	NAb will be measured using validated ECL methods.
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters	Baseline up to Day 22	Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.

Trial Locations

Locations (1)

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