Clinical trial NCT06127368: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: G2GBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 56
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sequential
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 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
measure: Clinical Laboratory tests
timeFrame: 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
measure: Vital Signs
timeFrame: 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
measure: Physical examination
timeFrame: 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
measure: Electrocardiograms
timeFrame: 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:
measure: Pharmacokinetics (Cmax)
timeFrame: 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
measure: Pharmacokinetics (Tmax)
timeFrame: 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
measure: Pharmacokinetics (Tlag)
timeFrame: 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
measure: Pharmacokinetics (AUCinf)
timeFrame: 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
measure: Pharmacokinetics (AUClast)
timeFrame: 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
measure: Pharmacokinetics (AUC 0-762)
timeFrame: 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
measure: Pharmacokinetics (CL/F)
timeFrame: 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
measure: Pharmacokinetics (Vd/F)
timeFrame: 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
measure: Pharmacokinetics (t1/2)
timeFrame: 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
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References: