drugset / Trial / NCT02768974
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.
Timeline
- Start
- 2016-09
- Primary completion
- 2017-02
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OPRX-106 | Protein / enzyme biologic | 2 mg | Oral |
| Subject | OPRX-106 | Protein / enzyme biologic | 8 mg | Oral |