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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: G2GBio, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	GB-5001A	Depending on the cohort, volume will be varied to administer, and the dosage and route of administration may be varied.
DRUG	GB-5001D	Depending on the cohort, volume will be varied to administer.
DRUG	Oral cohort	Single dose of Aricept tablet.

Timeline

• Start date: 2024-01-03
• Primary completion: 2024-09-17
• Completion: 2025-01-14
• First posted: 2023-11-13
• Last updated: 2023-12-22

Locations

1 site across 1 country: South Korea