A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533801
• Other study ID #: BAN2401-A001-005
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2022
• Est. completion date: January 6, 2023

Study information

• Verified date: March 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 6, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lecanemab
Lecanemab will be administered subcutaneously using a vial and syringe.
• Lecanemab
Lecanemab will be administered subcutaneously using AI.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab		0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Primary	AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab		0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Primary	Cmax: Maximum Observed Serum Concentration for Lecanemab		0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Primary	Tmax: Time to Reach the Maximum (Peak) Serum Concentration for Lecanemab		0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Primary	t1/2: Terminal Elimination Phase Half-life for Lecanemab		0 (Pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	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.	Up to Day 50
Secondary	Number of Participants With Abnormal Laboratory Values	Clinical laboratory parameters will include hematology, blood chemistry, and urinalysis.	Baseline up to Day 22
Secondary	Number of Participants With Abnormal Vital Signs Values	Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight.	Baseline up to Day 50
Secondary	Number of Participants With Anti-drug Antibodies (ADAs)	ADAs will be measured using validated electrochemiluminescent immunoassay methods.	Baseline up to Day 50
Secondary	Number of Participants With Neutralizing Antibodies (NAbs)	NAbs will be measured using validated electrochemiluminescent immunoassay methods.	Baseline up to Day 50