Clinical trial NCT05045716: A Study of Subcutaneous Lecanemab in Healthy Participants
Official title: An Open-label, Parallel-group, Randomized Study to Evaluate the Absolute Bioavailability of Single Dose Subcutaneous Administration of Lecanemab in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Lecanemab
Bioavailability
Subcutaneous
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

1. 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.
2. 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.
3. 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:

1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
2. 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
3. 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
4. Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing
5. 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
6. Prior exposure to lecanemab
7. Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment

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

Primary outcomes:
measure: AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
timeFrame: Days 0-50
measure: 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
timeFrame: 0-72 hours
measure: AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
timeFrame: Days 0-50
measure: F: Absolute Bioavailability of SC Formulation for Lecanemab
timeFrame: Days 0-50
measure: Cmax: Maximum Observed Serum Concentration for Lecanemab
timeFrame: Days 0-50
measure: Tmax: Time to Reach Maximum Serum Concentration for Lecanemab
timeFrame: Days 0-50
measure: T1/2: Terminal Elimination Half-life for Lecanemab
timeFrame: Days 0-50
Secondary outcomes:
measure: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 50
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: Baseline up to Day 22
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
timeFrame: Baseline up to Day 50
measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Day 50
measure: Number of Participants With Positive and Negative Anti-drug Antibody (ADA) for Lecanemab
timeFrame: Baseline Up to Day 50
measure: Number of Participants With Neutralizing Antibodies (NAb) for Lecanemab
timeFrame: Baseline up to Day 50
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
References: