GB004 in Adult Subjects With Active Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: GB004
* Drug: Placebo
* Drug: GB004


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB004<br>GB004 for oral administration daily | Drug: GB004<br>* GB0004 high dose<br>Drug: GB004<br>* GB004 low dose<br>|
| Placebo Comparator: Placebo<br>Placebo for oral administration daily | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004 |  | Day 1 to Day 28 | 
| Pharmacokinetics: Maximum Concentration (Cmax) of GB004 |  | Day 1 to Day 28 | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004 |  | Day 1 to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Ulcerative Colitis