Part B Cohort 7: E2025 Dose 4 for Healthy Subjects

Worldwide Clinical Trials, San Antonio, TX
Healthy SubjectsE2025 - Drug
Eligibility
18 - 55
All Sexes

Study Summary

This trial will study the safety and effects of an IV infusion of a new medicine in healthy adults.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Cohort 1
1
E2814
1
AZD8630

Study Objectives

6 Primary · 17 Secondary · Reporting Duration: Day 1: 0-24 hours up to Day 113

Day 113
Serum Concentration of Anti- E2025 Antibodies
Day 1: 0-24 hours
AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025
Part B, CSF AUC(0-24h): Area Under the CSF Concentration-time Curve From Time Zero to 24 hours for E2025
Part B: Ratio of AUC(0-24h) in CSF and AUC(0-24h) in Serum for E2025
Day 113
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Infinite for E2025
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Last Quantifiable Concentration for E2025
CL/F: Apparent Total Clearance for E2025
Cmax: Maximum Observed Serum Concentration for E2025
Tmax: Time to Reach Maximum Observed Serum Concentration (Cmax) for E2025
Vss: Volume of Distribution at Steady State for E2025
t1/2: Terminal Elimination Phase Half-life for E2025
Day 99
Part B, CSF Cmax: Maximum Observed CSF Concentration for E2025
Part B, CSF Tmax: Time to Reach Maximum Observed CSF Concentration (Cmax) for E2025
Part B: Ratio of Cmax in CSF and Cmax in Serum for E2025
Day 1: 0-672 hours
AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025
Day 1: 0-72 hours
AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025
Day 8
Part A: Cerebrospinal Fluid (CSF) Concentrations for E2025
Day 113
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
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Day 8
Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Cohort 1
1
E2814
1
AZD8630

Trial Design

7 Treatment Groups

Part A, Cohort 1: E2025 Dose 1 or Placebo
1 of 7
Part A, Cohort 2: E2025 Dose 2 or Placebo
1 of 7
Part B Cohort 7: E2025 Dose 4
1 of 7
Part B, Cohort 6: E2025 Dose 3
1 of 7
Part A, Cohort 3: E2025 Dose 3 or Placebo
1 of 7
Part A, Cohort 4: E2025 Dose 4 or Placebo
1 of 7
Part B, Cohort 5: E2025 Dose 2
1 of 7

Experimental Treatment

41 Total Participants · 7 Treatment Groups

Primary Treatment: Part B Cohort 7: E2025 Dose 4 · Has Placebo Group · Phase 1

Part A, Cohort 1: E2025 Dose 1 or PlaceboExperimental Group · 2 Interventions: E2025, Placebo · Intervention Types: Drug, Drug
Part A, Cohort 2: E2025 Dose 2 or PlaceboExperimental Group · 2 Interventions: E2025, Placebo · Intervention Types: Drug, Drug
Part B Cohort 7: E2025 Dose 4
Drug
Experimental Group · 1 Intervention: E2025 · Intervention Types: Drug
Part B, Cohort 6: E2025 Dose 3
Drug
Experimental Group · 1 Intervention: E2025 · Intervention Types: Drug
Part A, Cohort 3: E2025 Dose 3 or PlaceboExperimental Group · 2 Interventions: E2025, Placebo · Intervention Types: Drug, Drug
Part A, Cohort 4: E2025 Dose 4 or PlaceboExperimental Group · 2 Interventions: E2025, Placebo · Intervention Types: Drug, Drug
Part B, Cohort 5: E2025 Dose 2
Drug
Experimental Group · 1 Intervention: E2025 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1: 0-24 hours up to day 113

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
511 Previous Clinical Trials
151,656 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You weigh at least 50 kilograms and your body mass index (BMI) is between 18 and 30 kilograms per square meter (kg/m^2) at the time of screening.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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