NCT02618187

A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Seres Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Detailed description

This is a Phase 1b multicenter, randomized, double-blind, placebo-controlled multiple dose study designed to evaluate the safety and tolerability of SER-287, and to evaluate the microbiome alterations and pharmacodynamics associated with two dosing regimens of SER-287 in adult subjects with active mild-to-moderate ulcerative colitis (UC).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SER-287
DRUG	Placebo
DRUG	Placebo Pre-Treat
DRUG	Vancomycin Pre-Treat

Timeline

• Start date: 2016-01-13
• Primary completion: 2017-12-06
• Completion: 2018-01-26
• First posted: 2015-12-01
• Last updated: 2019-06-20
• Results posted: 2019-06-20

Locations

1 site across 1 country: United States