Anaphylaxis; Biosimilar Pharmaceuticals; Clinical Trial, Phase I; Drug Interactions; Endotoxemia; Research Design; Therapeutic Uses
- Haematology & Immunology
Our focus is to test newly developed drugs in sytemic or lung inflammation and hematologic patients. We combine in vitro, ex vivo and in vivo studies to obtain an integrated insight into pathophysiologic processes and pharmacodynamic actions of a drug. We have a strong background and interest in orphan diseases such as anaphylaxis, thrombotic thrombocytopenic purpura and currently cold agglutinin disease. We are specialised in innovated trial design including integrated study protocols and basket trial designs including first-in-human trials.
Techniques, methods & infrastructure
The department has got a phase I unit with 10 beds, where we perform first-in-human trials with biologics and small molecules, as well as phase I-III randomized controlled trials. We have established the human endotoxemia model to study drugs in systemic inflammation both for industry and academic purposes. Likewise we have established the endotoxin instillation into lungs in humans to investigate compartimentalized inflammatory responses and drug action. Platelet function tests including the platelet function analyzer and the multiple electrode aggregometry have been utilized in drug-drug interaction studies recently, where pharmacokinetics have been determined by tandem mass spectrometry. Thrombelastometric measurements and in vivo thrombin generation markers have been used for dose finding of novel anticoagulants and to examine specific pathophysiological changes. Flow-cytometry is used mainly to characterize in vivo changes of cellular blood components under drug treatment or inflammation.
- Cellular Mediators Linking Inflammation and Thrombosis (project part leader) (2013)
Source of Funding: FWF (Austrian Science Fund), Special Research Programmes (SFB54)
- Bartko, J. et al., 2018. A Randomized, First-in-Human, Healthy Volunteer Trial of BIVV009, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway. Clinical Pharmacology & Therapeutics. Available at: http://dx.doi.org/10.1002/cpt.1111.
- Peyvandi, F. et al., 2016. Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. New England Journal of Medicine, 374(6), pp.511-522. Available at: http://dx.doi.org/10.1056/NEJMoa1505533.
- Kubica, J. et al., 2015. Morphine delays and attenuates ticagrelor exposure and action in patients with myocardial infarction: the randomized, double-blind, placebo-controlled IMPRESSION trial. European Heart Journal, 37(3), pp.245-252. Available at: http://dx.doi.org/10.1093/eurheartj/ehv547.
- Ramsauer, K. et al., 2015. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. The Lancet Infectious Diseases, 15(5), pp.519-527. Available at: http://dx.doi.org/10.1016/S1473-3099(15)70043-5.
- Hobl, E.-L. et al., 2014. Morphine Decreases Clopidogrel Concentrations and Effects. Journal of the American College of Cardiology, 63(7), pp.630-635. Available at: http://dx.doi.org/10.1016/j.jacc.2013.10.068.