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
- Conditions
- Alzheimer Disease
- Interventions
- Registration Number
- NCT06127368
- Lead Sponsor
- G2GBio, Inc.
- 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 (donepezil) IM and SC single dose injection vs. active comparator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 56
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GB-5001A GB-5001A GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation. GB-5001D GB-5001D GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation. Oral cohort Oral cohort Aricept® tablet. The cohort is determined through random allocation.
- Primary Outcome Measures
Name Time Method Adverse Events 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 Number of participants with adverse events
Clinical Laboratory tests 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 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
Vital Signs 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 Incidence of abnormal clinically significant vital signs.(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature)
Physical examination 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 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.)
Electrocardiograms 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 Incidence of abnormal clinically significant ECG results (Ventricular rate (beats/min), PR interval (msec), QRS (msec), QT (msec), QTc (msec)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (AUClast) 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 Pharmacokinetics (Tmax) 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 Pharmacokinetics (AUCinf) 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 Pharmacokinetics (AUC 0-762) 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 Pharmacokinetics (CL/F) 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 Pharmacokinetics (Vd/F) 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 Pharmacokinetics (t1/2) 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 Pharmacokinetics (Tlag) 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 Pharmacokinetics (Cmax) 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
Trial Locations
- Locations (1)
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of