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

NCT05533801 | Completed Phase 1 FDA Drug

• 1 other identifier: BAN2401-A001-005
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

BAN2401; Lecanemab

Outcome Measures

Primary Outcomes (5)

• AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab

  0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

• AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab

  0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

• Cmax: Maximum Observed Serum Concentration for Lecanemab

  0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

• Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab

  0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

• t1/2: Terminal Elimination Phase Half-life for Lecanemab

  0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

Secondary Outcomes (5)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to Day 50

• Number of Participants With Abnormal Laboratory Values

  Baseline up to Day 22

• Number of Participants With Abnormal Vital Signs Values

  Baseline up to Day 50

• Number of Participants With Anti-drug Antibodies (ADAs)

  Baseline up to Day 50

• Number of Participants With Neutralizing Antibodies (NAbs)

  Baseline up to Day 50

Study Arms (2)

Treatment A: Lecanemab 720 mg

EXPERIMENTAL

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

Drug: Lecanemab

Treatment B: Lecanemab 720 mg

EXPERIMENTAL

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

Drug: Lecanemab

Interventions

Lecanemab DRUG

Lecanemab will be administered subcutaneously using a vial and syringe.

Also known as: BAN2401

Treatment A: Lecanemab 720 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Body Mass Index \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening

You may not qualify if:

• 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
• 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
• 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
• Prior exposure to lecanemab, or any other anti-amyloid therapies
• Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body \[mAb\]) treatment

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

lecanemab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 6, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: January 18, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)