Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
NCT04478825 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2021-10-01
Summary
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
Conditions
Interventions
- DRUG
-
BBT-401-1S
BBT-401-1S, 8 weeks, once a day
Sponsors & Collaborators
-
Covance
collaborator INDUSTRY -
Bridge Biotherapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2021-08-04
- Completion
- 2021-08-24
- FDA Drug
- Yes
Countries
- New Zealand
Study Locations
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