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Healthy VolunteersPhase 1NCT05533801

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 testing Lecanemab in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Lecanemab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
6 Sep 2022to 6 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing
  • Body Mass Index >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening

Who cannot join

  • Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  • Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
  • Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent
  • Prior exposure to lecanemab, or any other anti-amyloid therapies
  • Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body [mAb]) treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Anaheim Clinical Trials

    Anaheim, California, 92801

Other trials in United States

About this study

Official title: 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

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.

Being tested
Lecanemab
Keywords
BAN2401, Lecanemab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LecanemabDrug

    Also called BAN2401

    Lecanemab will be administered subcutaneously using a vial and syringe.

  • LecanemabDrug

    Also called BAN2401

    Lecanemab will be administered subcutaneously using AI.

Study groups in NCT05533801
Study groupRoleWhat they receive
Treatment A: Lecanemab 720 mgExperimentalParticipants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.
Receives: Drug: Lecanemab
Treatment B: Lecanemab 720 mgExperimentalParticipants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.
Receives: Drug: Lecanemab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab

    Measured: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

  2. AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab

    Measured: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

  3. Cmax: Maximum Observed Serum Concentration for Lecanemab

    Measured: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

  4. Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab

    Measured: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

  5. t1/2: Terminal Elimination Phase Half-life for Lecanemab

    Measured: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose

Secondary outcomes (5)

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    A TEAE is defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (baseline) or reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

    Measured: Up to Day 50

  2. Number of Participants With Abnormal Laboratory Values

    Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.

    Measured: Baseline up to Day 22

  3. Number of Participants With Abnormal Vital Signs Values

    Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight.

    Measured: Baseline up to Day 50

  4. Number of Participants With Anti-drug Antibodies (ADAs)

    ADAs will be measured using validated electrochemiluminescent immunoassay methods.

    Measured: Baseline up to Day 50

  5. Number of Participants With Neutralizing Antibodies (NAbs)

    NAbs will be measured using validated electrochemiluminescent immunoassay methods.

    Measured: Baseline up to Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2022
  2. Study start6 Sep 2022
  3. Primary completion6 Jan 2023
  4. Study completion6 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05533801
Sponsor's protocol ID
BAN2401-A001-005
Status last verified
Mar 2022
First submitted
6 Sep 2022
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lecanemab in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05533801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.

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