A Study of Subcutaneous Lecanemab in Healthy Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
Eisai Inc.
Study ID
NCT05045716
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.

Key Dates

Start date
Sep 7, 2021
Status verified
Sep 2021
Primary completion
Dec 7, 2021
Completion
Dec 7, 2021

Study Design

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

Arms

  • Experimental: Lecanemab 10 mg/kg
    Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1.
  • Experimental: Lecanemab 700 mg
    Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen 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: Days 0-50 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-

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