Before doing a phase I they do a smaller safety test in humans. This will be where they test 1cm².
"Phase 0 involves exploratory, first-in-human (FIH) trials that are run according to FDA guidelines. Also called human microdose studies, they have single sub-therapeutic doses given to 10 to 15 subjects and yield pharmacokinetic data or help with imaging specific targets without introducing pharmacological effects. Pharmaceutical companies perform Phase 0 studies to decide which of their drug candidates has the best pharmacokinetic parameters in humans."
While Profil Germany focuses on phase 1+2 clinical trials, a full understanding of the phases of clinical trials is essential.
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