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NCT05533801 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
160
Enrollment target

NCT05533801 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 160 participants.

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The verdict

NCT05533801, a Phase 1 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
160 participants
Enrollment target

Study 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.

Interventions

  • DRUG Lecanemab

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2022-09-06
Est. Completion 2023-01-06
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT05533801

The ClinicalTrials.gov registry entry for NCT05533801 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lecanemab is the first listed.

NCT05533801 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05533801 about?

NCT05533801 is a clinical study titled "A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants". 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.

What is the current status of trial NCT05533801?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2022-09-06. Estimated completion is 2023-01-06.

What interventions are being tested in trial NCT05533801?

The interventions under investigation include: Lecanemab (DRUG).

Who is sponsoring clinical trial NCT05533801?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.