GB004 in Adult Subjects With Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2019-12-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GB004, Inc.; GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Criteria

Inclusion Criteria:

• Patients aged 18-74, 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.