Crohn’s disease
Conditions
Brief summary
The primary endpoint of the study is safety and tolerability of MBF-118 administration for 28 days from baseline to end of the follow-up period at Day 56. Number and severity of AEs reported including Clinically Significant Changes in vital signs, physical examination, Laboratory Measurements, and ECGs.
Detailed description
Efficacy endpoints • Change from baseline (Day -1) of bowel wall thickness and color Doppler effect of stenosis at Day 28 and Day 56. • Change from baseline (Day -1) of fecal calprotectin at Day 28 and Day 56. • Change from baseline (Day 1) of plasma C-reactive protein at Day 28 and Day 56., Pharmacokinetics endpoints • Plasma: Cmax, Tmax, Area under curve (AUC) and Cmin in plasma at Day 1 and Day 28, and concentration on Day 56. • Feces: concentration of MBF-118 on Day 28 and Day 56, • GI tissue: Concentration of MBF-118 on Day 29.
Interventions
None listed
Sponsors
Medibiofarma S.L., Medibiofarma S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is safety and tolerability of MBF-118 administration for 28 days from baseline to end of the follow-up period at Day 56. Number and severity of AEs reported including Clinically Significant Changes in vital signs, physical examination, Laboratory Measurements, and ECGs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints • Change from baseline (Day -1) of bowel wall thickness and color Doppler effect of stenosis at Day 28 and Day 56. • Change from baseline (Day -1) of fecal calprotectin at Day 28 and Day 56. • Change from baseline (Day 1) of plasma C-reactive protein at Day 28 and Day 56., Pharmacokinetics endpoints • Plasma: Cmax, Tmax, Area under curve (AUC) and Cmin in plasma at Day 1 and Day 28, and concentration on Day 56. • Feces: concentration of MBF-118 on Day 28 and Day 56, • GI tissue: Concentration of MBF-118 on Day 29. | — |
Countries
Spain
Outcome results
None listed