Trials / Completed
CompletedNCT03705117
Open-label V565 Target Engagement Study
An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- VHsquared Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.
Detailed description
Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V565 | Capsules for oral administration |
Timeline
- Start date
- 2017-05-23
- Primary completion
- 2017-10-24
- Completion
- 2017-10-24
- First posted
- 2018-10-15
- Last updated
- 2018-10-15
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03705117. Inclusion in this directory is not an endorsement.