Healthy VolunteersPhase 1NCT04231513
A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants
A Phase 1 study testing E2814 in people with Healthy Volunteers, run by Eisai Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E2814
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Dec 2019to 9 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Nonsmoking, healthy participants.
- Japanese participants must satisfy the following requirements:
- Must have been born in Japan to Japanese parents and Japanese grandparents
- Must have lived no more than 5 years outside of Japan
- Must not have changed their life style or habits, including diet, while living outside of Japan
Who cannot join
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Females who are breastfeeding or pregnant at Screening or Baseline
- Females of childbearing potential who within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- total abstinence (if it is their preferred and usual lifestyle)
- an intrauterine device or intrauterine hormone-releasing system
- a contraceptive implant
Show all 28Show fewer
- an oral contraceptive (Participants must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 16 weeks after study drug discontinuation)
- have a vasectomized partner with confirmed azoospermia Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 16 weeks after study drug discontinuation NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex, or synthetic condoms throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation
- 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
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline
- A prolonged QT (that is, corrected QT interval [QTc] Fridericia interval greater than [>] 450 milliseconds) demonstrated on ECG at Screening or Baseline. A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome)
- Persistent systolic blood pressure (SBP) >130 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) >85 mmHg at Screening or Baseline. One repeat measurement will be allowed
- Heart rate less than 45 or more than 100 beats per minute at Screening or Baseline
- Known history of clinically significant drug allergy at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
- Any history of hypersensitivity reaction to a foreign protein, with clinical features of Grades 2 to 4 as described in National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, immunoglobulin A (IgA) deficiency, or significant autoimmune disease or disorder. Participants with hypersensitivity reactions to foreign protein with clinical features limited to nasal or conjunctival symptoms such as in allergic rhinitis do not need to be excluded
- Known to be human immunodeficiency virus (HIV) positive at Screening
- Active or chronic (including asymptomatic) viral hepatitis (A, B or C) as demonstrated by positive serology at Screening. For hepatitis B serology, this refers to positive for hepatitis B core antibody (HBcAb, Immunoglobulin M [IgM] type) or hepatitis B surface or core antigens (HBsAg, HBcAg). For hepatitis C serology, a positive result for screening serological testing must be confirmed by qualitative hepatitis C virus ribonucleic acid (RNA)
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline
- Intake of over-the-counter medications within 2 weeks before dosing
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
- Exposure to any biologic drug within 90 days or at least 5 half-lives (whichever is longer), or within 4 weeks for vaccines, before Screening, with the exception of influenza and COVID-19 vaccinations that are allowed up to 7 days before dosing
- Engagement in strenuous exercise within 2 weeks before check-in (example, marathon runners, weight lifters, etc.)
- Any contraindication to continuous cerebrospinal fluid (CSF) sampling via indwelling lumbar catheter or via lumbar puncture (LP)
- Any history of or current blood clotting or bleeding disorder that is not under adequate control, including a platelet count less than (<) 50,000, international normalized ratio (INR) >1.3, or partial thromboplastin time (PTT) >upper limit of normal (ULN), or fibrinogen <1.8 gram per liter (g/L) or >4.3 g/L at Screening or Baseline. Participants receiving anticoagulation therapy or identified at risk for hemorrhage
- Any lifetime suicidal behavior or psychiatric disease. Whenever possible, medical records should be reviewed to confirm absence of history of psychiatric disease or use of medications to treat psychiatric disease
- Any current or prior history of suicidal behavior or psychiatric disease identified by the psychiatrist at the Screening Visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
California Clinical Trials Medical Group/Parexel International
Glendale, California, 91206
Worldwide Clinical Trials
San Antonio, Texas, 78217
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2814 in Healthy Subjects
The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants.
Read the detailed description
The study is comprised of two components: a single ascending dose (SAD) component and a multiple ascending dose (MAD) component. The SAD component consists of 5 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive a single dose of E2814 or E2814-matched placebo. The MAD component of the study consists of 4 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive E2814 or E2814-matched placebo every 4 weeks (Q4W) on 3 occasions.
- Conditions
- Healthy Volunteers
- Being tested
- E2814, E2814-matched placebo
- Keywords
- E2814, Healthy Participants, Phase 1, Pharmacokinetics, Pharmacodynamics, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2814Drug
E2814, intravenous infusion.
E2814-matched placeboDrug
E2814-matched placebo, intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| SAD, Cohort 1: E2814 or E2814-matched Placebo | Experimental | Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. Receives: Drug: E2814; Drug: E2814-matched placebo |
| SAD, Cohort 2: E2814 or E2814-matched Placebo | Experimental | Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. Receives: Drug: E2814; Drug: E2814-matched placebo |
| SAD, Cohort 3: E2814 or E2814-matched Placebo | Experimental | Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. Receives: Drug: E2814; Drug: E2814-matched placebo |
| SAD, Cohort 4: E2814 or E2814-matched Placebo | Experimental | Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. Receives: Drug: E2814; Drug: E2814-matched placebo |
| SAD, Cohort 5: E2814 or E2814-matched Placebo | Experimental | Participants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. Receives: Drug: E2814; Drug: E2814-matched placebo |
| MAD, Cohort 1: E2814 or E2814-matched Placebo | Experimental | Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. Receives: Drug: E2814; Drug: E2814-matched placebo |
| MAD, Cohort 2: E2814 or E2814-matched Placebo | Experimental | Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. Receives: Drug: E2814; Drug: E2814-matched placebo |
| MAD, Cohort 3: E2814 or E2814-matched Placebo | Experimental | Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. Receives: Drug: E2814; Drug: E2814-matched placebo |
| MAD, Cohort 4: E2814 or E2814-matched Placebo | Experimental | Participants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. Receives: Drug: E2814; Drug: E2814-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 113 days
SAD, Number of Participants With Clinically Significant Laboratory Values
Measured: Up to 113 days
SAD, Number of Participants With Clinically Significant Vital Signs Values
Measured: Up to 113 days
SAD, Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Measured: Up to 113 days
MAD, Number of Participants With TEAEs and SAEs
Measured: Up to 169 days
MAD, Number of Participants With Clinically Significant Laboratory Values
Measured: Up to 169 days
MAD, Number of Participants With Clinically Significant Vital Signs Values
Measured: Up to 169 days
MAD, Number of Participants With Clinically Significant ECG Findings
Measured: Up to 169 days
Secondary outcomes (44)
SAD, Cmax Serum: Maximum Observed Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Measured: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Measured: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Serum: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Serum: Terminal Elimination Phase Half-life for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Serum: Clearance for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Serum: Volume of Distribution for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Serum anti-E2814 Antibody Concentration
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Cmax CSF: Maximum Observed Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, Tmax CSF: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Measured: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, AUC (0-24h) CSF: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Measured: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, Cmax Plasma: Maximum Observed Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Measured: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Measured: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Plasma: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Plasma: Terminal Elimination Phase Half-life for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Plasma: Clearance for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Plasma: Volume of Distribution for E2814
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Plasma anti-E2814 Antibody Concentration
Measured: Pre-dose (Day 1) and up to Day 113 Post Dose
MAD, Cmax Serum: Maximum Observed Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Measured: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Measured: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Serum: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Serum: Terminal Elimination Half-life for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Serum: Clearance for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Vz Serum: Volume of Distribution for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(Cmax) Serum: Ratio of Accumulation for Cmax for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(AUC) Serum: Ratio of Accumulation for AUC for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Serum anti-E2814 Antibody Concentration
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CSF Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 85 Post Dose
MAD, Cmax Plasma: Maximum Observed Concentration for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Measured: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Measured: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Plasma: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Plasma: Terminal Elimination Half-life for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Plasma: Clearance for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Vz Plasma: Volume of Distribution for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(Cmax) Plasma: Ratio of Accumulation for Cmax for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(AUC) Plasma: Ratio of Accumulation for AUC for E2814
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Plasma anti-E2814 Antibody Concentration
Measured: Pre-dose (Day 1) and up to Day 169 Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start16 Dec 2019
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231513
- Sponsor's protocol ID
- E2814-A001-001
- Status last verified
- Apr 2023
- First submitted
- 14 Jan 2020
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2814 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04231513
- Acronym / sponsor ID
- E2814-A001-001
- Conditions
- Healthy Volunteers
- Keywords
- E2814, Healthy Participants, Phase 1, Pharmacokinetics, Pharmacodynamics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants.
Detailed description
The study is comprised of two components: a single ascending dose (SAD) component and a multiple ascending dose (MAD) component. The SAD component consists of 5 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive a single dose of E2814 or E2814-matched placebo. The MAD component of the study consists of 4 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive E2814 or E2814-matched placebo every 4 weeks (Q4W) on 3 occasions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAD, Cohort 1: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. |
| SAD, Cohort 2: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. |
| SAD, Cohort 3: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. |
| SAD, Cohort 4: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. |
| SAD, Cohort 5: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive either E2814 or E2814-matched placebo as an intravenous infusion, once, on Day 1. |
| MAD, Cohort 1: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. |
| MAD, Cohort 2: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. |
| MAD, Cohort 3: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. |
| MAD, Cohort 4: E2814 or E2814-matched Placebo | Experimental | Drug: E2814, Drug: E2814-matched placeboParticipants will receive E2814 or E2814-matched placebo as an intravenous infusion Q4W on 3 occasions up to Day 57 of the Treatment Period. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Nonsmoking, healthy participants.
- Must have been born in Japan to Japanese parents and Japanese grandparents
- Must have lived no more than 5 years outside of Japan
- Must not have changed their life style or habits, including diet, while living outside of Japan
Key exclusion criteria (28 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Females who are breastfeeding or pregnant at Screening or Baseline
- Females of childbearing potential who within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex, or synthetic condoms throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2814E2814, intravenous infusion. | Drug | MAD, Cohort 1: E2814 or E2814-matched Placebo, MAD, Cohort 2: E2814 or E2814-matched Placebo, MAD, Cohort 3: E2814 or E2814-matched Placebo, MAD, Cohort 4: E2814 or E2814-matched Placebo, SAD, Cohort 1: E2814 or E2814-matched Placebo, SAD, Cohort 2: E2814 or E2814-matched Placebo, SAD, Cohort 3: E2814 or E2814-matched Placebo, SAD, Cohort 4: E2814 or E2814-matched Placebo, SAD, Cohort 5: E2814 or E2814-matched Placebo |
| E2814-matched placeboE2814-matched placebo, intravenous infusion. | Drug | MAD, Cohort 1: E2814 or E2814-matched Placebo, MAD, Cohort 2: E2814 or E2814-matched Placebo, MAD, Cohort 3: E2814 or E2814-matched Placebo, MAD, Cohort 4: E2814 or E2814-matched Placebo, SAD, Cohort 1: E2814 or E2814-matched Placebo, SAD, Cohort 2: E2814 or E2814-matched Placebo, SAD, Cohort 3: E2814 or E2814-matched Placebo, SAD, Cohort 4: E2814 or E2814-matched Placebo, SAD, Cohort 5: E2814 or E2814-matched Placebo |
Primary outcome
SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Vital Signs Values
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Up to 113 days
MAD, Number of Participants With TEAEs and SAEs
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant Vital Signs Values
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant ECG Findings
Time frame: Up to 169 days
44 secondary outcomes
SAD, Cmax Serum: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Serum: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Serum: Terminal Elimination Phase Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Serum: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Serum: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Serum anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Cmax CSF: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, Tmax CSF: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, AUC (0-24h) CSF: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, Cmax Plasma: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Plasma: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Plasma: Terminal Elimination Phase Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Plasma: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Plasma: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Plasma anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
MAD, Cmax Serum: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Serum: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Serum: Terminal Elimination Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Serum: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Vz Serum: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(Cmax) Serum: Ratio of Accumulation for Cmax for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(AUC) Serum: Ratio of Accumulation for AUC for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Serum anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CSF Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 85 Post Dose
MAD, Cmax Plasma: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Plasma: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Plasma: Terminal Elimination Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Plasma: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2814 in people with Healthy Volunteers, run by Eisai Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to 113 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.