After manufacturing sufficient amounts of the NCE, formulating it for use in humans to treat diseases, and after toxicological evaluation the drug can be tested in humans.
Clinical development of an NCE is performed by the responsible company in phases: It is first tested in healthy human volunteers (Phase I) to determine the drug`s safety and pharmacokinetic properties. Subsequently, a Phase II study tests safety and efficacy of the drug first in small, then in larger cohorts of patients. Before submission of all documents for obtaining approval, large Phase III studies in patients at different sites are required.
Clinical trials are usually run under the supervision of an expert physician in the field (Principal Investigator, PI). They are monitored and audited by specialized CROs and ensure the adherence to the study protocol and strict guidelines. Polyphor has established a network of physicians and experts in the field for its clinical, but also preclinical projects for collaborations and clinical studies. In clinical development, Polyphor also has established collaborations with the premier CROs to establish high quality clinical studies.