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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127368
• Other study ID #: GB5001A101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 3, 2024
• Est. completion date: January 14, 2025

Study information

• Verified date: November 2023
• Source: G2GBio, Inc.
• Contact: Jimin Hwang
• Phone: 82-2-400-2681
• Email: clinicalstudy[@]g2gbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 14, 2025
• Est. primary completion date: September 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
G2GBio, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with 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
Primary	Clinical Laboratory tests	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	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
Primary	Vital Signs	Incidence of abnormal clinically significant vital signs.(Systolic and Diastolic Blood Pressure, Pulse Rate, Body Temperature)	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
Primary	Physical examination	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.)	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
Primary	Electrocardiograms	Incidence of abnormal clinically significant ECG results (Ventricular rate (beats/min), PR interval (msec), QRS (msec), QT (msec), QTc (msec)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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