GB004 in Adult Subjects With Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860896
• Other study ID #: GB004-1101
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: January 2020
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• GB004
GB0004 high dose
• Placebo
Placebo
• GB004
GB004 low dose

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine	Tbilisi
Moldova, Republic of	PMSI Republican Clinical Hospital "Timofei Mosneaga"	Chisinau
United States	Delta Research Partners	Monroe	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Countries where clinical trial is conducted

United States,  Georgia,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.	56 Days
Secondary	Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004		Day 1 to Day 28
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of GB004		Day 1 to Day 28
Secondary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004		Day 1 to Day 28