Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05726851
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2023-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Screening up to Day 113'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Laboratory Values', 'timeFrame': 'Screening up to Day 113'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Vital Signs Values', 'timeFrame': 'Screening up to Day 113'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings', 'timeFrame': 'Screening up to Day 113'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Physical Examinations Findings', 'timeFrame': 'Screening up to Day 113'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings', 'timeFrame': 'Screening up to Day 8'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Serum Concentration for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'Tmax: Time to Reach Maximum Observed Serum Concentration (Cmax) for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Last Quantifiable Concentration for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Infinite for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025', 'timeFrame': 'Day 1: 0-24 hours'}, {'measure': 'AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025', 'timeFrame': 'Day 1: 0-72 hours'}, {'measure': 'AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025', 'timeFrame': 'Day 1: 0-672 hours'}, {'measure': 't1/2: Terminal Elimination Phase Half-life for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'CL/F: Apparent Total Clearance for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'Vss: Volume of Distribution at Steady State for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 113'}, {'measure': 'Part A: Cerebrospinal Fluid (CSF) Concentrations for E2025', 'timeFrame': 'Pre-dose; Days 8 and 29 post-dose'}, {'measure': 'Part B, CSF Cmax: Maximum Observed CSF Concentration for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 99'}, {'measure': 'Part B, CSF Tmax: Time to Reach Maximum Observed CSF Concentration (Cmax) for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 99'}, {'measure': 'Part B, CSF AUC(0-24h): Area Under the CSF Concentration-time Curve From Time Zero to 24 hours for E2025', 'timeFrame': 'Day 1: 0-24 hours'}, {'measure': 'Part B: Ratio of Cmax in CSF and Cmax in Serum for E2025', 'timeFrame': 'Day 1: 0-24 hours up to Day 99'}, {'measure': 'Part B: Ratio of AUC(0-24h) in CSF and AUC(0-24h) in Serum for E2025', 'timeFrame': 'Day 1: 0-24 hours'}, {'measure': 'Serum Concentration of Anti- E2025 Antibodies', 'timeFrame': 'Day 1 up to Day 113'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['E2025', 'Healthy Participants'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-smoking, male or female age greater than or equal to (\\>=) 18 years and less than or equal to (\\<=) 55 years old at the time of informed consent. Females must be of nonchildbearing potential\n* Body weight \\>=50 kilogram (kg) and a Body Mass Index (BMI) \\>=18 and less than (\\<) 30 kilogram per square meter (kg/m\\^2) at Screening\n\nExclusion Criteria:\n\n* Females who are breastfeeding or pregnant at Screening or Baseline; Females of childbearing potential.\n* Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period or for 203 days after their partner's study drug administration.\n* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing\n* 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\n* Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening\n* A prolonged QT/QTc interval (QTcF \\>450 millisecond \\[ms\\]). A history of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval\n* Persistent systolic blood pressure (BP) greater than 130 millimeter of mercury (mmHg) or diastolic BP greater than 85 mmHg at Screening or Baseline; Heart rate less than 50 or more than 100 beats per minute at Screening or Baseline\n* Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-suicide Severity Rating Scale (C-SSRS) or equivalent scale or via interview with a psychiatrist\n* Any lifetime history of psychiatric disease (including but not limited to depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, anxiety disorders); any current psychiatric symptoms as indicated by a standard screening tool.\n* Known history of clinically significant drug allergy; known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening\n* Any history of hypersensitivity reaction to a foreign protein, with clinical features not limited to nasal or conjunctival symptoms such as in allergic rhinitis\n* Known to be human immunodeficiency virus positive and/or active viral hepatitis (hepatitis B core antibody \\[HBcAb\\], hepatitis B viral protein \\[HBcAg\\], hepatitis B surface antigen \\[HBsAg\\], hepatitis C virus antibody \\[HCVAb\\]) as demonstrated by positive serology at Screening\n* History of drug or alcohol dependency or abuse within the 2 years before Screening, or a positive urine drug test or breath alcohol test at Screening or Baseline\n* Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5\\*the half-life, whichever is longer) preceding informed consent\n* Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing\n* 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 flu (7 days before dosing) and COVID-19 vaccination (14 days before dosing until after the Follow-up visit).\n* Any contraindication to continuous CSF sampling via indwelling lumbar catheter or via lumbar puncture (LP)\n* Participants identified at risk for hemorrhage.\n* Inadequate venous access that would interfere with study drug administration or obtaining blood samples\n* Participants who contravene the restrictions on concomitant medications, food, beverages, physical activities, and others as defined in the protocol"}, 'identificationModule': {'nctId': 'NCT05726851', 'briefTitle': 'A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A First-in-Human, Single Ascending Dose and Pharmacokinetic/Pharmacodynamic Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Intravenous Infusions of E2025 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'E2025-A001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 1: E2025 Dose 1 or Placebo', 'description': 'Participants will receive E2025 Dose 1 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 2: E2025 Dose 2 or Placebo', 'description': 'Participants will receive E2025 Dose 2 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 3: E2025 Dose 3 or Placebo', 'description': 'Participants will receive E2025 Dose 3 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 4: E2025 Dose 4 or Placebo', 'description': 'Participants will receive E2025 Dose 4 or E2025 matching placebo (normal saline) administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 5: E2025 Dose 2', 'description': 'Participants will receive E2025 Dose 2 administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 6: E2025 Dose 3', 'description': 'Participants will receive E2025 Dose 3 administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Cohort 7: E2025 Dose 4', 'description': 'Participants will receive E2025 Dose 4 administered as an IV infusion on Day 1.', 'interventionNames': ['Drug: E2025']}], 'interventions': [{'name': 'E2025', 'type': 'DRUG', 'description': 'E2025 IV infusion.', 'armGroupLabels': ['Part A, Cohort 1: E2025 Dose 1 or Placebo', 'Part A, Cohort 2: E2025 Dose 2 or Placebo', 'Part A, Cohort 3: E2025 Dose 3 or Placebo', 'Part A, Cohort 4: E2025 Dose 4 or Placebo', 'Part B Cohort 7: E2025 Dose 4', 'Part B, Cohort 5: E2025 Dose 2', 'Part B, Cohort 6: E2025 Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'E2025 matched placebo IV infusion.', 'armGroupLabels': ['Part A, Cohort 1: E2025 Dose 1 or Placebo', 'Part A, Cohort 2: E2025 Dose 2 or Placebo', 'Part A, Cohort 3: E2025 Dose 3 or Placebo', 'Part A, Cohort 4: E2025 Dose 4 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}