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A Seamless Phase 1b Study to Evaluate Safety, Tolerability and Efficacy of SER-301 in Adult Subjects with Active Mild-to-Moderate Ulcerative Colitis

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Trial Profile

A Seamless Phase 1b Study to Evaluate Safety, Tolerability and Efficacy of SER-301 in Adult Subjects with Active Mild-to-Moderate Ulcerative Colitis

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2022

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At a glance

  • Drugs SER 301 (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions
  • Sponsors Seres Therapeutics

Most Recent Events

  • 01 Mar 2022 According to a Seres Therapeutics media release, company has completed preliminary data analysis data from the first cohort of the SER-301 Phase 1b study in subjects with mild-to-moderate UC, which included 15 subjects. Evaluation of the first cohort data by an independent Data Safety Monitoring Board indicated that it would be safe to proceed to the placebo-controlled second cohort.
  • 03 Nov 2021 Status changed from recruiting to active, no longer recruiting.
  • 23 Sep 2021 Planned initiation date changed from 28 Sep 2020 to 28 Dec 2021.

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