Trials / Unknown
UnknownNCT02768974
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Protalix · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPRX-106 | Oral delivery, once daily. |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-02-01
- First posted
- 2016-05-11
- Last updated
- 2016-09-28
Locations
7 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02768974. Inclusion in this directory is not an endorsement.