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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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