Overview

A Study of Subcutaneous Lecanemab in Healthy Participants

Status:
Recruiting

Trial end date:
2021-12-07

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Eisai Inc.

Criteria

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.