GB004 in Adult Subjects With Active Ulcerative Colitis



Status:Not yet recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/7/2019
Start Date:June 2019
End Date:February 2020
Contact:Gossamer Bio, Inc.
Email:ClinicalTrials@gossamerbio.com
Phone:1-866-668-4083

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis

This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to
evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative
colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be
assessed.

The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in
a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis
(UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004
serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

Inclusion Criteria:

- Patients aged 18-75, receiving therapy for active ulcerative colitis confirmed by Mayo
Score assessment, and evidence of colonic inflammation.

Exclusion Criteria:

- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or
parasitic infection.

- Patients receiving biologic agents and experimental agents are excluded.
We found this trial at
1
site
Delta Research Partners, LLC
Monroe, Louisiana 71201
?
mi
from
Monroe, LA
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