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SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Clostridium Difficile Infection Clinical Trial

Official title:
A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence

Clinical Trial Summary

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Clinical Trial Description

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02830542
Study type Interventional
Source Seres Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2016
Completion date August 2018
View Details
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