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

Part of paid clinical trials in Anaheim, California.

Sponsor
Eisai Inc.
Study ID
NCT05533801
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Lecanemab — DRUG
    Lecanemab will be administered subcutaneously using a vial and syringe.
  • Lecanemab — DRUG
    Lecanemab will be administered subcutaneously using AI.

Study Details

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.

Key Dates

Start date
Sep 6, 2022
Status verified
Mar 2022
Primary completion
Jan 6, 2023
Completion
Jan 6, 2023

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab [ Time Frame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials· Anaheim, CA

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