Alzheimer Disease
Conditions
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.
Interventions
DRUGGB-5001A
Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.
DRUGGB-5001D
Depending on the cohort, volume will be varied to administer.
DRUGOral cohort
Single dose of Aricept tablet.
Sponsors
G2GBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
sequential
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 (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 |
| 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 (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 (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 (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 (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 (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 |
Countries
South Korea
Contacts
Primary ContactJimin Hwang
Backup ContactSangsub Lee
Outcome results
None listed