Trials / Completed
CompletedNCT05533801
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
An Open-Label, Parallel-Group, Randomized Study to Demonstrate the Bioequivalence of the Subcutaneous Formulation of Lecanemab Supplied in Vials and a Single-Use Auto-Injector
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lecanemab | Lecanemab will be administered subcutaneously using a vial and syringe. |
| DRUG | Lecanemab | Lecanemab will be administered subcutaneously using AI. |
Timeline
- Start date
- 2022-09-06
- Primary completion
- 2023-01-06
- Completion
- 2023-01-06
- First posted
- 2022-09-09
- Last updated
- 2023-01-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05533801. Inclusion in this directory is not an endorsement.