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A Safety and Tolerability Study of GB301

NCT03865017 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-08-05

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple intravenous (IV) infusions at a single dose strength of GB301 in subjects with mild to moderate AD.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

Regulatory T cells

The trial will be carried out in Alzheimer's disease patients. The investigators will isolate CD4+CD25+ Tregs from these patients, expand and injection.

OTHER

Saline

Saline+cell suspension solution infusion

Sponsors & Collaborators

  • BHT Lifescience Austrailia Pty Ltd.

    collaborator UNKNOWN

  • VTBIO Co. LTD

    lead INDUSTRY

Principal Investigators

  • Jaeyoon Kim · Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-12-01
Completion
2021-12-01

Countries

  • Australia

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 NCT03865017 on ClinicalTrials.gov