drugset / Trial / NCT05852574
CP101 for the Treatment of Ulcerative Colitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a dose ranging exploratory phase 1 pilot study to assess engraftment, safety, and efficacy of CP101, an oral microbiome therapeutic, in participants with active mild-to-moderate Ulcerative colitis. A total of 30 patients who meet eligibility criteria will be randomized 1:1 to either a short or extended induction dosing with CP101. An assessment of the microbiome will occur at baseline, Day 6, Week 4, Week 8, Week 12, Week 16, and Week 24.
Timeline
- Start
- 2023-09-01
- Primary completion
- 2024-11-21
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CP101 | Other / unclassified | 5 unknown | Oral |