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Clinical Trial Summary

Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial


Clinical Trial Description

This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05943041
Study type Interventional
Source GI Biome, Inc.
Contact Sujin Kim, Ph.D.
Phone +82-31-8035-3240
Email sujin.kim@gi-biome.com
Status Recruiting
Phase Phase 1
Start date April 28, 2023
Completion date December 31, 2023

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