Phase I Unit

The division of Clinical Research at Fraunhofer IME in Frankfurt has a modern Phase I unit. Here the early stages of clinical drug development (e.g. pharmacokinetic, pharmacodynamic and bioequivalence studies) can be carried out under optimal conditions. An experienced and well trained study team of physicians and study nurses is in charge and takes care of our study participants during all stages of their treatment.

Closely located to the university hospital it is our claim to develop the best study design together with our customers. Special expertise and academic background for research fields of immune-mediated and inflammatory diseases are the basics for our success. Unique features are the close cross linking to the clinical divisions of the Goethe University Hospital and the connection to special clinical diagnostics.

Our goal is the realization of challenging clinical trials in the early phases of drug development with highest quality standards and under the highest level of safety for our study participants.

Selected Publications

Prophylaxis of hereditary angioedema attacks: A randomized trial of oral plasma kallikrein inhibition with avoralstat. Aygören-Pürsün E, Magerl M, Graff J, Martinez-Saguer I, Kreuz W, Longhurst H, Nasr I, Bas M, Straßen U, Fang L, Cornpropst M, Dobo S, Collis P, Sheridan WP, Maurer M. J Allergy Clin Immunol. 2016 Sep;138(3):934-936.e5. http://doi.org/10.1016/j.jaci.2016.03.043. Epub 2016 May 11.

Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers—results of a dose escalation trial. Karpova D, Bräuninger S, Wiercinska E, Krämer A, Stock B, Graff J, Martin H, Wach A, Escot C, Douglas G, Romagnoli B, Chevalier E, Dembowski K, Hooftman L, Bonig H. J Transl Med; 2017 Jan 3;15(1):2. http://doi.org/10.1186/s12967-016-1107-2.