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

Sponsor

G2GBio, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06127368

Collaborator

(none)

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: GB-5001A Drug: GB-5001D Drug: Oral cohort	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

sequentialsequential

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 3, 2024

Anticipated Primary Completion Date :

Sep 17, 2024

Anticipated Study Completion Date :

Jan 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GB-5001A GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.	Drug: GB-5001A Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.
Experimental: GB-5001D GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.	Drug: GB-5001D Depending on the cohort, volume will be varied to administer.
Active Comparator: Oral cohort Aricept® tablet. The cohort is determined through random allocation.	Drug: Oral cohort Single dose of Aricept tablet.

Arm

Intervention/Treatment

Experimental: GB-5001A

GB-5001 Suspension for IM/SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.

Drug: GB-5001A

Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.

Experimental: GB-5001D

GB-5001 Suspension for SC injection at three doses(low, intermediate, high) The cohort is determined through random allocation.

Drug: GB-5001D

Depending on the cohort, volume will be varied to administer.

Active Comparator: Oral cohort

Aricept® tablet. The cohort is determined through random allocation.

Drug: Oral cohort

Single dose of Aricept tablet.

Outcome Measures

Primary Outcome Measures

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

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 (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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Hospital	Daejeon		Korea, Republic of

Sponsors and Collaborators

G2GBio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

G2GBio, Inc.

ClinicalTrials.gov Identifier:

NCT06127368

Other Study ID Numbers:

GB5001A101

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Nov 18, 2023