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A first-in-man, randomised, double-blind, placebo-controlled, healthy volunteer study with a single administration phase (SAD – single ascending dose) and a multiple administration phase (MAD - multiple ascending dose) design to study the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ODS-101

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Trial Profile

A first-in-man, randomised, double-blind, placebo-controlled, healthy volunteer study with a single administration phase (SAD – single ascending dose) and a multiple administration phase (MAD - multiple ascending dose) design to study the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ODS-101

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Oct 2024

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At a glance

  • Drugs ODS 101 (Primary)
  • Indications Inflammatory bowel diseases
  • Focus Adverse reactions; First in man

Most Recent Events

  • 22 Oct 2024 Results (n=72) assessing the safety and tolerability of OPM-101 in healthy volunteers, published in the Oncodesign Biotechnology Media Release
  • 22 Oct 2024 According to Oncodesign Precision Medicine media release, the final results of this trial describing strong safety data and no cardiac toxicity were published, paving the way for the launch of phase 1b/2a.
  • 15 Oct 2024 According to an Oncodesign Precision Medicine media release, data from this study has been presented at the United European Gastroenterology (UEG) Week congress, October 12-15, 2024, in Vienna, Austria.

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