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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB004 | Experimental | GB004 for oral administration daily |
|
| Placebo | Placebo Comparator | Placebo for oral administration daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB004 | Drug | GB0004 high dose |
| |
| Placebo |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Research Partners | Monroe | Louisiana | 71201 | United States | ||
| Arensia Exploratory Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35014040 | Derived | Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
Placebo |
|
| GB004 | Drug | GB004 low dose |
|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004 |
| Day 1 to Day 28 |
| Tbilisi |
| 0112 |
| Georgia |
| PMSI Republican Clinical Hospital "Timofei Mosneaga" | Chisinau | MD2025 | Moldova |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |