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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: Completed Phase 1 study, sponsored by Eisai.

NCT05533801 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Eisai

287 total trials

What the finished NCT05533801 record still lists

NCT05533801 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher).

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

NCT05533801 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05533801's enrollment target sits among peer trials

160 340th of 2000 higher than 1,655 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05533801, the US trial registry maintained by the National Library of Medicine. NCT05533801 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.