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Completed

NCT Number: NCT05045716

A Study of Subcutaneous Lecanemab in Healthy Participants

The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.

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Key information

Conditions

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

Participants must meet all of the following criteria to be included in this study:

  • Non-smoking, male or female, age greater than or equal to (>=) 18 years and less than or equal to (<=) 65 years old at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
  • Japanese participants (age >=20 years) must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan.
  • Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at screening.

Exclusion criteria

Participants who meet any of the following criteria will be excluded from this study:

  • Clinically significant illness that requires medical treatment within 8 weeks 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 subjects who have a congenital abnormality in metabolism
  • Exposure within the last 14 days before dosing to an individual with confirmed or probable corona virus disease-2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection
  • Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing
  • 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
  • Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment

NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Lecanemab

Drug

Lecanemab IV infusion.

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: Days 0-50

  2. AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 Hours Post End of Intravenous (IV) Infusion or SC Administration for Lecanemab

    Time frame: 0-72 hours

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

    Time frame: Days 0-50

  4. F: Absolute Bioavailability of SC Formulation for Lecanemab

    Time frame: Days 0-50

    Absolute bioavailability (F) = [AUC(0-inf) SC*Dose (IV)]/[AUC(0-inf) IV*Dose (SC)]. IV dose will be based on total dose (mg) infused.

  5. Cmax: Maximum Observed Serum Concentration for Lecanemab

    Time frame: Days 0-50

  6. Tmax: Time to Reach Maximum Serum Concentration for Lecanemab

    Time frame: Days 0-50

  7. T1/2: Terminal Elimination Half-life for Lecanemab

    Time frame: Days 0-50

Secondary outcomes

  1. Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 50

  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

    Time frame: Baseline up to Day 22

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

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values

    Time frame: Baseline up to Day 50

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

  4. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings

    Time frame: Baseline up to Day 50

  5. Number of Participants With Positive and Negative Anti-drug Antibody (ADA) for Lecanemab

    Time frame: Baseline Up to Day 50

    ADA will be measured using validated electrochemiluminescent immunoassay (ECL) methods.

  6. Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab

    Time frame: Baseline up to Day 50

    NAb will be measured using validated ECL methods.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Jan 19, 2022

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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