UnknownPhase 1

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

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

Lead sponsor

G2GBio, Inc.

Assets

GB-5001A / GB-5001D

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age 19-55•Male

Primary endpoints

•Adverse Events•Clinical Laboratory tests•Vital Signs

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDGB5001A101

NCT IDNCT06127368

Timeline

Milestones

Study first posted2023-11-13actual

Last update posted2023-12-22actual

Study start2024-01-03estimated

Primary completion2024-09-17estimated

Study completion2025-01-14estimated

Assets

Drug assets

GB-5001A GB-5001D

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age19 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Adverse Events

Time frame: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

event count, event

Primary/protocol endpoint

Vital Signs

Time frame: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

event count, event

Secondary/protocol endpoint

Pharmacokinetics (Cmax)