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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-smoking, male or female age >=18 years and <=55 years old at the time of informed consent. Females must be of nonchildbearing potential
Body weight >=50 kilogram (kg) and a Body Mass Index (BMI) >=18 and <30 kilogram per square meter (kg/m^2) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: 0-24 hours up to day 113
Awards & highlights
Study Summary
This trial will study the safety and effects of an IV infusion of a new medicine in healthy adults.
Who is the study for?
This trial is for non-smoking adults aged 18-55 who are not pregnant, breastfeeding, or able to become pregnant. Participants must have a body weight of at least 50 kg and a BMI between 18 and <30. They should not have any significant medical conditions, abnormal test results requiring treatment, drug/alcohol abuse history in the past two years, or be taking certain medications.Check my eligibility
What is being tested?
The study tests E2025's safety when given as a single IV infusion to healthy people compared with a placebo (a substance with no active drug). It looks at how the body reacts to it (pharmacodynamics) and how it moves through and out of the body (pharmacokinetics).See study design
What are the potential side effects?
While specific side effects aren't listed since this is an early-phase trial assessing safety in healthy volunteers, potential side effects could include reactions at the infusion site, allergic responses due to foreign protein sensitivity, or other unforeseen reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a non-smoker, aged 18-55, and cannot become pregnant.
Select...
I weigh at least 50 kg and my BMI is between 18 and 30.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1: 0-24 hours up to day 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: 0-24 hours up to day 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Number of Participants With Clinically Significant Abnormal Laboratory Values
Number of Participants With Clinically Significant Abnormal Physical Examinations Findings
+3 moreSecondary outcome measures
AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025
AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025
AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025
+14 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part B, Cohort 6: E2025 Dose 3Experimental Treatment1 Intervention
Participants will receive E2025 Dose 3 administered as an IV infusion on Day 1.
Group II: Part B, Cohort 5: E2025 Dose 2Experimental Treatment1 Intervention
Participants will receive E2025 Dose 2 administered as an IV infusion on Day 1.
Group III: Part B Cohort 7: E2025 Dose 4Experimental Treatment1 Intervention
Participants will receive E2025 Dose 4 administered as an IV infusion on Day 1.
Group IV: Part A, Cohort 4: E2025 Dose 4 or PlaceboExperimental Treatment2 Interventions
Participants will receive E2025 Dose 4 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Group V: Part A, Cohort 3: E2025 Dose 3 or PlaceboExperimental Treatment2 Interventions
Participants will receive E2025 Dose 3 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Group VI: Part A, Cohort 2: E2025 Dose 2 or PlaceboExperimental Treatment2 Interventions
Participants will receive E2025 Dose 2 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Group VII: Part A, Cohort 1: E2025 Dose 1 or PlaceboExperimental Treatment2 Interventions
Participants will receive E2025 Dose 1 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E2025
2023
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670
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
153,988 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe allergic reactions to foreign proteins, which can cause symptoms beyond just nasal or eye-related issues like in allergic rhinitis.I am not pregnant, breastfeeding, and if I can have children, I agree to use birth control.I am a male without a successful vasectomy and my partner can still have children.I have no symptoms or test results that need treatment right now.My heart's electrical cycle is longer than normal, or I take medications that can extend this cycle.My blood pressure is high or my heart rate is not between 50-100 beats per minute.I have not participated in another clinical study or used any investigational drugs or devices within the last 28 days.I haven't received blood products in the last 4 weeks or donated blood or plasma recently.I am at risk for bleeding.I haven't taken any biologic drugs recently, except for flu and COVID-19 vaccines.I am a non-smoker, aged 18-55, and cannot become pregnant.I weigh at least 50 kg and my BMI is between 18 and 30.You have ever had thoughts of hurting yourself or attempting suicide, as assessed by a standardized questionnaire or a conversation with a psychiatrist.You have a history of severe reactions to medications or certain foods, or you are currently experiencing significant allergies.I haven't needed treatment for a serious illness or infection in the last 8 weeks.I cannot have a lumbar catheter or lumbar puncture due to health reasons.I do not have any major health issues that could affect the study results.You have ever had a mental health condition such as depression, bipolar disorder, schizophrenia, or anxiety. You are currently experiencing mental health symptoms as shown by a test.
Research Study Groups:
This trial has the following groups:- Group 1: Part B, Cohort 6: E2025 Dose 3
- Group 2: Part B Cohort 7: E2025 Dose 4
- Group 3: Part A, Cohort 4: E2025 Dose 4 or Placebo
- Group 4: Part B, Cohort 5: E2025 Dose 2
- Group 5: Part A, Cohort 1: E2025 Dose 1 or Placebo
- Group 6: Part A, Cohort 2: E2025 Dose 2 or Placebo
- Group 7: Part A, Cohort 3: E2025 Dose 3 or Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age limit for those wishing to participate in this experiment?
"Eligible participants for this medical trial must be aged 18 or over, but no more than 55 years old."
Answered by AI
Are there any qualifications for participating in this research?
"In order to be accepted into this research, subjects should have no major medical conditions and must fall between 18-55 years of age. A total of 41 study volunteers are being sought after."
Answered by AI
Are there still opportunities to partake in this investigation?
"According to clinicaltrials.gov, this research is no longer recruiting participants. Initially posted on February 6th 2023 and last updated on March 2nd 2023, the study has since closed its recruitment period yet 827 other studies are enrolling patients presently."
Answered by AI
Is Part B, Cohort 6: E2025 Dose 3 likely to produce adverse effects in patients?
"Due to the fact that Part B, Cohort 6: E2025 Dose 3 is in its initial testing phase, our team at Power classified it as a 1 on the safety scale. This implies there is limited clinical data available for evaluating efficacy and security."
Answered by AI
Who else is applying?
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
Why did patients apply to this trial?
This trial is close to me and I’d like to make a difference in people’s lives by doing whatever I can.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Is there required overnights?
PatientReceived no prior treatments
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