Status:
UNKNOWN
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
Lead Sponsor:
G2GBio, Inc.
Conditions:
Alzheimer Disease
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
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 (d...
Eligibility Criteria
Inclusion
- Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit
- 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
- Subjects with the following medical history or symptoms, as determined by the Principal Investigator to pose a risk to the trial.
- 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
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 14 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06127368
Start Date
January 3 2024
End Date
January 14 2025
Last Update
December 22 2023
Active Locations (1)
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1
Chungnam National University Hospital
Daejeon, South Korea