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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Delta Research Partners
Monroe, Louisiana, United States
Arensia Exploratory Medicine
Tbilisi, Georgia
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, Moldova
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.
Time frame: 56 Days
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Time frame: Day 1 to Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Time frame: Day 1 to Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
Time frame: Day 1 to Day 28
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