A Study to Assess Safety, Tolerability, Pharmacokinetics (PK), Immunogenicity, and Pharmacodynamics (PD) of Intravenous Infusions of E2814 in Healthy Participants

NCT04231513 | Completed Phase 1 FDA Drug

• 1 other identifier: E2814-A001-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteers

Keywords

E2814; Healthy Participants; Phase 1; Pharmacokinetics; Pharmacodynamics; Immunogenicity

Outcome Measures

Primary Outcomes (8)

• SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 113 days

• SAD, Number of Participants With Clinically Significant Laboratory Values

  Up to 113 days

• SAD, Number of Participants With Clinically Significant Vital Signs Values

  Up to 113 days

• SAD, Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

  Up to 113 days

• MAD, Number of Participants With TEAEs and SAEs

  Up to 169 days

• MAD, Number of Participants With Clinically Significant Laboratory Values

  Up to 169 days

• MAD, Number of Participants With Clinically Significant Vital Signs Values

  Up to 169 days

• MAD, Number of Participants With Clinically Significant ECG Findings

  Up to 169 days

Secondary Outcomes (44)

• SAD, Cmax Serum: Maximum Observed Concentration for E2814

  Pre-dose (Day 1) and up to Day 113 Post Dose

• SAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814

  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

  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

  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

  Pre-dose (Day 1) and up to Day 113 Post Dose

Study Arms (9)

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: E2814; Drug: E2814-matched placebo

Interventions

E2814 DRUG

E2814, intravenous infusion.

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 placebo DRUG

E2814-matched placebo, intravenous infusion.

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

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

California Clinical Trials Medical Group/Parexel International

Glendale, California, 91206, United States

Location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: December 16, 2019
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)