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Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

NCT04596293 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-09-07

Study results available
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Summary

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

Conditions

Interventions

DRUG

BBT-401-1S or Placebo

Administered by 200mg capsules of BBT-401-1S or placebo

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2022-05-17
Completion
2022-07-12
FDA Drug
Yes

Countries

  • United States
  • Poland
  • South Korea
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596293 on ClinicalTrials.gov