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Monoclonal Antibodies

E2814 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose (day 1) and up to day 169 post dose
Awards & highlights

Study Summary

This trial will test how safe and tolerable a new drug is in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose (day 1) and up to day 169 post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (day 1) and up to day 169 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
MAD, Number of Participants With Clinically Significant ECG Findings
MAD, Number of Participants With Clinically Significant Laboratory Values
MAD, Number of Participants With Clinically Significant Vital Signs Values
+5 more
Secondary outcome measures
MAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
MAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
MAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
+41 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: SAD, Cohort 5: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1.
Group II: SAD, Cohort 4: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1.
Group III: SAD, Cohort 3: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1.
Group IV: SAD, Cohort 2: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1.
Group V: SAD, Cohort 1: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1.
Group VI: MAD, Cohort 4: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period.
Group VII: MAD, Cohort 3: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period.
Group VIII: MAD, Cohort 2: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period.
Group IX: MAD, Cohort 1: E2814 or E2814-matched PlaceboExperimental Treatment2 Interventions
Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E2814
2019
Completed Phase 1
~80
E2814-matched placebo
2019
Completed Phase 1
~80

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
153,948 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of participants in this research endeavor?

"Affirmative. The online database hosted by clinicaltrials.gov reveals that this medical experiment, initiated on December 16th 2019, is actively searching for participants. 72 individuals are being requested from 2 distinct healthcare facilities."

Answered by AI

Does this study accept geriatric participants?

"This study is open to participants between 20 and 55 years of age. There are separate studies for those under 18 (50) and over 65 (373)."

Answered by AI

Are there still openings for volunteers to join the trial?

"Affirmative, the information posted on clinicaltrials.gov states that this research venture is currently in search of appropriate candidates. This investigation was initially made public on December 16th 2019 and last updated August 2nd 2022; 72 participants need to be sourced from two different trial sites."

Answered by AI

Has E2814 been sanctioned by the Food and Drug Administration?

"Our team at Power assessed the potential risk associated with E2814 to be low, rating it a 1 due to limited data concerning its safety and efficacy as this is currently in Phase I."

Answered by AI

Do I meet the prerequisites for participating in this medical research?

"This research is searching for 72 individuals between 20-55 years of age who meet the following criteria: 1. Habitual non-smokers, 2. Born to Japanese parents and grandparents in Japan, 3. No more than 5 consecutive years spent abroad from Japan, 4. Unaltered lifestyle habits while living overseas (including diet)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Worldwide Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants
2019. "A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04231513.
~13 spots leftby Apr 2025
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