A Study of Subcutaneous Lecanemab in Healthy Participants

NCT05045716 | Completed Phase 1 FDA Drug

• 1 other identifier: BAN2401-A001-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Lecanemab; Bioavailability; Subcutaneous

Outcome Measures

Primary Outcomes (7)

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

  Days 0-50

• 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

  0-72 hours

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

  Days 0-50

• F: Absolute Bioavailability of SC Formulation for Lecanemab

  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.

  Days 0-50

• Cmax: Maximum Observed Serum Concentration for Lecanemab

  Days 0-50

• Tmax: Time to Reach Maximum Serum Concentration for Lecanemab

  Days 0-50

• T1/2: Terminal Elimination Half-life for Lecanemab

  Days 0-50

Secondary Outcomes (6)

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

  Baseline up to Day 50

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

  Baseline up to Day 22

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

  Baseline up to Day 50

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

  Baseline up to Day 50

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

  Baseline Up to Day 50

Study Arms (2)

Lecanemab 10 mg/kg

EXPERIMENTAL

Participants will receive lecanemab 10 milligram per kilogram (mg/kg), as single dose IV infusion over approximately 1 hour on Day 1.

Drug: Lecanemab

Lecanemab 700 mg

EXPERIMENTAL

Participants will receive lecanemab 700 milligram (mg), as single fixed dose SC injection in the abdomen on Day 1.

Drug: Lecanemab

Interventions

Lecanemab DRUG

Lecanemab IV infusion.

Also known as: BAN2401

Lecanemab 10 mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

lecanemab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: September 7, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: January 19, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)