Trials / Completed
CompletedNCT02818686
TD-1473 for Active Ulcerative Colitis (UC)
A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TD-1473 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-10-03
- Primary completion
- 2018-03-29
- Completion
- 2018-03-29
- First posted
- 2016-06-30
- Last updated
- 2021-09-30
Locations
8 sites across 4 countries: United States, Georgia, Moldova, Romania
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02818686. Inclusion in this directory is not an endorsement.