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

NCT06127368 | Unknown Phase 1

• 1 other identifier: GB5001A101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• 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

Study Arms (3)

GB-5001A

EXPERIMENTAL

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

Drug: GB-5001A

GB-5001D

EXPERIMENTAL

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

Drug: GB-5001D

Oral cohort

ACTIVE COMPARATOR

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

Drug: Oral cohort

Interventions

GB-5001A DRUG

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

GB-5001A

GB-5001D DRUG

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

GB-5001D

Oral cohort DRUG

Single dose of Aricept tablet.

Oral cohort

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G2GBio, Inc.: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jimin Hwang

CONTACT

82-2-400-2681; clinicalstudy@g2gbio.com

Sangsub Lee

CONTACT

82-2-400-2694; clinicalstudy@g2gbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: sequential

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 3, 2024
• Primary Completion: September 17, 2024
• Study Completion: January 14, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-11

Locations

KR (1)