At TRACER we are specialized in first-in-human studies with the use of nuclear and optical molecular imaging techniques.
By labeling an antibody, small molecule, peptide, nanoparticle, protein, or any other compound of interest with a fluorescent dye or a radionuclide, fast in human data can be obtained with an indication of the potential efficacy of the novel drug, even before the classical phase 1-3 clinical trials. This can lead to a more efficient and less costly drug development process.
We assist our sponsors in the labeling of their lead compounds and execute first-in-human studies to visualize and quantify the biodistribution and pharmacokinetics of the compound. With this information a “ go/no-go” decision can be made before the compound proceeds to the next phase in clinical development where costs are larger and time is valuable.
Early in-human studies are approved by the EMA and FDA through the so-called principle of microdosing. It allows you to often skip (large) animal models and go straight into the patient population.