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

G2GBio

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: GB-5001D; Drug: Oral cohort; Drug: GB-5001A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06127368

GB5001A101

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

GB-5001A

Experimental group

Description:

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

Treatment:

Drug: GB-5001A

GB-5001D

Experimental group

Description:

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

Treatment:

Drug: GB-5001D

Oral cohort

Active Comparator group

Description:

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

Treatment:

Drug: Oral cohort