@trying2learn,
Someone is blowing smoke up someone’s dress.
Unless something has changed radically in less than a decade a true FIH study would NOT contain 5000 people, 20 to maybe 80 would be the number. A time frame of months is normal for an FIH but three years? Level II and even some level III studies usually only contain a couple hundred and normally terminate in a year or less.
As FIH is to determine ONLY drug safety (is it lethal) there are a large number of protocols that must be followed about information and assured understanding of information so it is hard to believe that at the point of signing consent forms you would still have this level of ignorance on the subject.
None of this sounds real -- to me.