FIM Trials as a very special type of early clinical safety trials are mentioned above, but there are more questions that might have to be answered in dedicated safety studies in healthy subjects or patients. In the broader sense, the multiple-ascending dose (MAD) trial, usually the second trial in a clinical development program, is a special safety trial as well.
Inamed’s clinical pharmacology experts will be able to set up a most efficient clinical development plan from FIM to Proof-of-Concept (PoC) taking into account the non-clinical data, your target product profile and all other relevant information.
A Thorough-QT (TQT) Trial is a dedicated safety trial that might have to be conducted for some investigational compounds under certain conditions. More information on special design issues of TQT trials are given below.