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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • G2GBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127368 on ClinicalTrials.gov