Clinical trial NCT05533801: A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BAN2401
Lecanemab
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-09
Enrollment: 160
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 demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Body Mass Index \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening

Exclusion Criteria:

1. 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
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 participants who have a congenital abnormality in metabolism
3. 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
4. Prior exposure to lecanemab, or any other anti-amyloid therapies
5. Hypersensitivity to lecanemab or any of the excipients, or to any (monoclonal anti-body \[mAb\]) treatment

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: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
measure: AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
timeFrame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
measure: Cmax: Maximum Observed Serum Concentration for Lecanemab
timeFrame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
measure: Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab
timeFrame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
measure: t1/2: Terminal Elimination Phase Half-life for Lecanemab
timeFrame: 0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 50
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Baseline up to Day 22
measure: Number of Participants With Abnormal Vital Signs Values
timeFrame: Baseline up to Day 50
measure: Number of Participants With Anti-drug Antibodies (ADAs)
timeFrame: Baseline up to Day 50
measure: Number of Participants With Neutralizing Antibodies (NAbs)
timeFrame: Baseline up to Day 50
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
References: