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

NCT ID: NCT05533801

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-01-06

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment A: Lecanemab 720 mg

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

Group Type: EXPERIMENTAL

Lecanemab

Intervention Type: DRUG

Lecanemab will be administered subcutaneously using a vial and syringe.

Treatment B: Lecanemab 720 mg

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

Group Type: EXPERIMENTAL

Lecanemab

Intervention Type: DRUG

Lecanemab will be administered subcutaneously using AI.

Interventions

Lecanemab

Lecanemab will be administered subcutaneously using a vial and syringe.

Intervention Type: DRUG

Lecanemab

Lecanemab will be administered subcutaneously using AI.

Intervention Type: DRUG

Other Intervention Names

BAN2401; BAN2401

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anaheim Clinical Trials

Anaheim, California, United States

Countries

United States

Other Identifiers

BAN2401-A001-005

Identifier Type: -

Identifier Source: org_study_id