A Study of Subcutaneous Lecanemab in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045716
• Other study ID #: BAN2401-A001-004
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: September 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lecanemab
Lecanemab IV infusion.
• Lecanemab
Lecanemab SC injection.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab		Days 0-50
Primary	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
Primary	AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab		Days 0-50
Primary	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
Primary	Cmax: Maximum Observed Serum Concentration for Lecanemab		Days 0-50
Primary	Tmax: Time to Reach Maximum Serum Concentration for Lecanemab		Days 0-50
Primary	T1/2: Terminal Elimination Half-life for Lecanemab		Days 0-50
Secondary	Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 50
Secondary	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
Secondary	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
Secondary	Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings		Baseline up to Day 50
Secondary	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
Secondary	Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab	NAb will be measured using validated ECL methods.	Baseline up to Day 50