drugset / 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

NCT06127368

Phase 1 Unknown 56 enrolled G2GBio, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-03
Primary completion
2024-09-17
Completion
2025-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule Intramuscular

Indications