Reference project
Tissue selective insulin concentrations in adipose tissue
aOFM was successfully used to measure insulin concentrations and time-resolved profiles in a clinical trial
Injection in the subcutaneous adipose tissue is an important application route for many substances such as insulin or antibodies. Drug depot formation in adipose tissue and drug distribution are crucial for assessing uptake into the blood, pharmaceutical effects or potential side effects. aOFM studies provide data regarding substance distribution in adipose tissue and pharmacodynamic effects in the target tissue.
Ex-vivo experiments are performed with freshly explanted human and animal tissues.
Our study designs include animal models in awake and anesthetized animals ranging from rodents to primates.
Clinical studies range from first-in-human studies to clinical stage phase 0 or phase 1 studies, where subcutaneously applied drugs can be monitored for up to 36 hours using aOFM or microdialysis. Clinical studies can be conducted in healthy volunteers or patients (diabetes type 1 and 2, acne, psoriasis…). Drug concentrations and PD markers are analyzed in our GLP certified lab.
Multiple probes per application site allow for an efficient study design which delivers a large amount of reliable data while using only a relatively small number of subjects in PK/PD studies.
Clinical trials are conducted according to ICH-GCP standards at the Clinical Trials Unit of the Medical University of Graz.
Combination of microdialysis and OFM technologies for protein-binding studies.
Injection device tests and optimization: Using live in-vivo imaging techniques (e.g. µCT) to visualize an injected substance depot directly in the tissue.
Various glucose clamps techniques (hypo, hyper, eugylcaemic) to determine glucose infusion rate, insulin onset time,…
Studies using isotope labelled insulins to monitor glucose metabolism (endogenous glucose production and peripheral glucose uptake)
aOFM was successfully used to measure insulin concentrations and time-resolved profiles in a clinical trial