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A three-part, double-blind, placebo-controlled, Phase I/Ib study of the safety, tolerability and pharmacokinetics of single and multiple ascending doses of IMU-856 in healthy volunteers and patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohns disease.

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Trial Profile

A three-part, double-blind, placebo-controlled, Phase I/Ib study of the safety, tolerability and pharmacokinetics of single and multiple ascending doses of IMU-856 in healthy volunteers and patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohns disease.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Feb 2025

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At a glance

  • Drugs IMU 856 (Primary)
  • Indications Coeliac disease; Crohn's disease; Inflammatory bowel diseases; Irritable bowel syndrome; Ulcerative colitis
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Immunic

Most Recent Events

  • 20 Feb 2025 According to an Immunic media release, company announced that they will present data of this trial as a digital oral presentation at the 19th Congress of ECCO (European Crohns and Colitis Organisation).
  • 13 Nov 2024 According to an Immunic media release, company announced that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology.
  • 29 Oct 2024 According to an Immunic media release, data from this study will be presented at the Symposium 238: Immuno-Mediated Diseases of the GI Tract: Where Do We Stand? in Florence, Italy.

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