In general, clinical trials consist of four different phases.

  • Phase I: This is the first time that new pharmaceuticals are administered to humans in order to find the suitable dose and to evaluate the general tolerability of the new drug.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: Application, efficacy and safety of the pharmaceutical are confirmed by hundreds or up to thousands of trial participants.
  • Phase IV: This subsequent trial aims to find out whether the therapy can be improved and if there are further indications for which the approved pharmaceutical or therapeutic concept can be applied.

The GANNET53 trial is a two-part trial, containing phase I and phase II respectively.
(For more information see GANNET53 – Schedule of the trial)

 

What is a “multicentre, international” trial?

A multicentre study is a clinical trial conducted at more than one medical centre, trial site or clinic. In the case of the GANNET53 trial, 18 sites in four countries (Austria, Germany, Belgium and France) will conduct this trial together.