Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 8:33 PM
Study NCT ID:
NCT06127368
Status:
UNKNOWN
Last Update Posted:
2023-12-22
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015331', 'term': 'Cohort Studies'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'sequential'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-01-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Part A: Cohort A, B : Upto Day 106 / Cohort C : Upto Day 71 / Cohort D : Upto Day 18, Part B: Cohort E, F, M : Upto Day 18 or Day 106', 'description': 'Number of participants with adverse events'}, {'measure': 'Clinical Laboratory tests', 'timeFrame': 'Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99', 'description': 'Incidence of abnormal clinically significant clinical laboratory test results. (Hematology, Blood Chemistry Test, Urine Test, Blood Coagulation Test, Serum Test and Urine Drug Screening Test.) /Day 1 to Day'}, {'measure': 'Vital Signs', 'timeFrame': 'Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99', 'description': 'Incidence of abnormal clinically significant vital signs.(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature)'}, {'measure': 'Physical examination', 'timeFrame': 'Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99', 'description': 'Incidence of abnormal clinically significant Physical examination. (This includes an evaluation of the overall appearance and a review of the physical organ systems through questioning, visual inspection, and palpation.)'}, {'measure': 'Electrocardiograms', 'timeFrame': 'Part A: Cohort A, B : Upto Day 99 / Cohort C : Upto Day 64 / Cohort D : Upto Day 11, Part B: Cohort E, F, M : Upto Day 64 or Day 99', 'description': 'Incidence of abnormal clinically significant ECG results (Ventricular rate (beats/min), PR interval (msec), QRS (msec), QT (msec), QTc (msec)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (Cmax)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (Tmax)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (Tlag)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (AUCinf)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (AUClast)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (AUC 0-762)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (CL/F)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (Vd/F)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}, {'measure': 'Pharmacokinetics (t1/2)', 'timeFrame': 'Part A: Cohort A, B : upto Day 99 / Cohort C : upto Day 64 / Cohort D : Upto Day 11 , Part B: Cohort E, F, M : upto Day 11 or Day 99'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults. And, It is to evaluate pharmacokinetic characteristics of GB-5001 (donepezil) IM and SC single dose injection vs. active comparator.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit\n* Subject with a body weight of 55 kg or more and a body mass index (BMI) equal to or greater than 18.5 kg/m² but less than 30 kg/m²\n* Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination\n* Subject who has been deemed suitable based on screening test results assessed by the principal investigator\n* Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures\n\nExclusion Criteria:\n\n* Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.\n\n * Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.\n * Rhabdomyolysis\n * Seizure, Epilepsy, Fainting\n * peptic ulcer or gastrointestinal hemorrhage\n * Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion\n * Severe physical/organ abnormalities\n * Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus\n* Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.\n\n * Medications, including antidepressants, that can induce Rhabdomyolysis\n * Medications with a risk of ulcer development.\n * Potent inhibitors of cytochrome P450 (CYP) enzymes\n * Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors\n* Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access\n* Subjects who have been consistently engaging in excessive smoking or consuming caffeine or alcohol within the last 3 months prior to screening, or Subjects who cannot abstain from smoking, caffeine, and alcohol consumption for at least 2 days before the scheduled administration of the investigational product or during the inpatient period'}, 'identificationModule': {'nctId': 'NCT06127368', 'briefTitle': 'Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'G2GBio, Inc.'}, 'officialTitle': 'An Open-label, Active-controlled, Parallel and Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'GB5001A101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GB-5001A', 'description': 'GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.', 'interventionNames': ['Drug: GB-5001A']}, {'type': 'EXPERIMENTAL', 'label': 'GB-5001D', 'description': 'GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.', 'interventionNames': ['Drug: GB-5001D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral cohort', 'description': 'Aricept® tablet. The cohort is determined through random allocation.', 'interventionNames': ['Drug: Oral cohort']}], 'interventions': [{'name': 'GB-5001A', 'type': 'DRUG', 'description': 'Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.', 'armGroupLabels': ['GB-5001A']}, {'name': 'GB-5001D', 'type': 'DRUG', 'description': 'Depending on the cohort, volume will be varied to administer.', 'armGroupLabels': ['GB-5001D']}, {'name': 'Oral cohort', 'type': 'DRUG', 'description': 'Single dose of Aricept tablet.', 'armGroupLabels': ['Oral cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hong', 'role': 'CONTACT'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'centralContacts': [{'name': 'Jimin Hwang', 'role': 'CONTACT', 'email': 'clinicalstudy@g2gbio.com', 'phone': '82-2-400-2681'}, {'name': 'Sangsub Lee', 'role': 'CONTACT', 'email': 'clinicalstudy@g2gbio.com', 'phone': '82-2-400-2694'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G2GBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}