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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lecanemab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05533801

BAN2401-A001-005

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Treatment A: Lecanemab 720 mg

Experimental group

Description:

Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.

Treatment:

Drug: Lecanemab

Treatment B: Lecanemab 720 mg

Experimental group

Description:

Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.

Treatment:

Drug: Lecanemab