A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
- 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.
- Short title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-01-06
- First posted
- 2022-09-09
- Registry last updated
- 2023-01-18
- Primary completion date
- 2023-01-06
- Start date
- 2022-09-06
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eisai Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05533801
- ClinicalTrials.gov ID
- NCT05533801
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
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
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
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
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
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
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: 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.
Number of Participants With Abnormal Laboratory Values
Timeframe: Baseline up to Day 22
Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.
Number of Participants With Abnormal Vital Signs Values
Timeframe: 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.
Number of Participants With Anti-drug Antibodies (ADAs)
Timeframe: Baseline up to Day 50
ADAs will be measured using validated electrochemiluminescent immunoassay methods.
Number of Participants With Neutralizing Antibodies (NAbs)
Timeframe: Baseline up to Day 50
NAbs will be measured using validated electrochemiluminescent immunoassay methods.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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
- 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
- Anaheim Clinical TrialsAnaheim, United States