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
NCT ID: NCT06127368
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
56 participants
INTERVENTIONAL
2024-01-03
2025-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GB-5001A
GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
GB-5001A
Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.
GB-5001D
GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.
GB-5001D
Depending on the cohort, volume will be varied to administer.
Oral cohort
Aricept® tablet. The cohort is determined through random allocation.
Oral cohort
Single dose of Aricept tablet.
Interventions
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GB-5001A
Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.
GB-5001D
Depending on the cohort, volume will be varied to administer.
Oral cohort
Single dose of Aricept tablet.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subject without congenital or chronic conditions, and with no pathological symptoms or findings on internal medical examination
* Subject who has been deemed suitable based on screening test results assessed by the principal investigator
* Subject who can understand this clinical trial, provide informed written consent prior to the clinical trial procedures
Exclusion Criteria
* Renal/Genitourinary, Gastrointestinal, Cardiovascular, Cerebrovascular, Pulmonary, Endocrine, Immune, Musculoskeletal, Neurological, Psychiatric, Dermatological, and Hematological conditions.
* Rhabdomyolysis
* Seizure, Epilepsy, Fainting
* peptic ulcer or gastrointestinal hemorrhage
* Gastrointestinal pathology, uncontrollable gastrointestinal symptoms or a history of disturbing absorption, distribution, metabolism or excretion
* Severe physical/organ abnormalities
* Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus
* Subjects with a history of, or currently receiving, the following medications, as determined by the Principal Investigator regarded as a risk to the trial.
* Medications, including antidepressants, that can induce Rhabdomyolysis
* Medications with a risk of ulcer development.
* Potent inhibitors of cytochrome P450 (CYP) enzymes
* Anticholinergic drugs, cholinomimetics, and other cholinesterase inhibitors
* Subjects who have difficulty with venipuncture or injection procedures via catheter or intravenous access
* 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
19 Years
55 Years
MALE
Yes
Sponsors
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G2GBio, Inc.
INDUSTRY
Responsible Party
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Locations
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Chungnam National University Hospital
Daejeon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hong
Role: primary
Other Identifiers
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GB5001A101
Identifier Type: -
Identifier Source: org_study_id