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Completed

NCT Number: NCT05533801

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lecanemab

Drug

Lecanemab will be administered subcutaneously using a vial and syringe.

Other names: BAN2401

Primary outcomes

  1. 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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

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

    Time frame: Up to Day 50

    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.

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: Baseline up to Day 22

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

  3. Number of Participants With Abnormal Vital Signs Values

    Time frame: Baseline up to Day 50

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

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

    Time frame: Baseline up to Day 50

    ADAs will be measured using validated electrochemiluminescent immunoassay methods.

  5. Number of Participants With Neutralizing Antibodies (NAbs)

    Time frame: Baseline up to Day 50

    NAbs will be measured using validated electrochemiluminescent immunoassay methods.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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