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Monoclonal Antibodies

Treatment A: Lecanemab 720 mg for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
Awards & highlights

Study 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

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 4, 8, 24, 48, 72, 96, 120, 168, 336, 504, 696, 840, 1176 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration for Lecanemab
Cmax: Maximum Observed Serum Concentration for Lecanemab
+2 more
Secondary outcome measures
Number of Participants With Abnormal Laboratory Values
Number of Participants With Abnormal Vital Signs Values
Number of Participants With Anti-drug Antibodies (ADAs)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B: Lecanemab 720 mgExperimental Treatment1 Intervention
Participants will receive a single SC dose of lecanemab 720 mg in the lower abdomen using AI on Day 1.
Group II: Treatment A: Lecanemab 720 mgExperimental Treatment1 Intervention
Participants will receive a single SC dose of lecanemab 720 milligram (mg) in the lower abdomen using a vial and syringe on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lecanemab
2022
Completed Phase 1
~220

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
153,939 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the drug Lecanemab 720 mg endorsed by the FDA?

"With limited clinical data available to assess the safety and efficacy of Treatment A: Lecanemab 720 mg, it is estimated to receive a score of 1."

Answered by AI

Is this research actively looking for participants?

"Clinicaltrials.gov displays that, although initially posted on September 6th 2022 and last amended November 22nd 2022, this medical trial is not presently enlisting participants. Nonetheless, there are 841 other studies actively recruiting patients at the present time."

Answered by AI

Can individuals aged 50 or more take part in this trial?

"Eligibility for this trial stipulates that patients must be between the ages of 18 and 65. However, there are 50 trials specifically targeting those under 18 years old as well as 373 studies aimed at individuals over the age of 65."

Answered by AI

What prerequisites must one fulfill in order to qualify for participation in this clinical trial?

"To qualify for this trial, potential participants should be in good health and between the ages of 18 to 65. A total of 160 people are being accepted into the study."

Answered by AI

What objectives are researchers hoping to accomplish from this research endeavor?

"According to the trial sponsor, Eisai Inc., the primary outcome measured over a 0 (Pre-dose), 4, 8, 24, 48, 72 etc. post-dose period is AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Time Extrapolated to Infinity for Lecanemab. Additionally, this study will assess secondary metrics such as Abnormal Vital Signs Values (BP/Pulse Rate/Respiratory Rate/Body Temp./Weight), Abnormal Laboratory Parameters (Hematology/Chemistry/Urinalysis) and Anti-drug Antib"

Answered by AI
~64 spots leftby Mar 2025