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

GB5001A101

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.

2024-01-03

2024-09-17

2025-01-14

Recruiting

Early phase I

56

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'sequential', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

2023-12-22