b'THE ALTASCIENTISTPlanning Your First-in-Human TrialTypically,FIHtrialswithcompoundsintendedfortreatmentof diseases other than cancers or certain rare non-malignant diseases are conducted using normal healthy volunteers (NHVs), unless there is an ethical concern (such as known toxicity) in administering the investigational drug to an otherwise healthy population.DuringanFIHstudy,yourobjectivesmayincludeevaluating safetyandtolerance,determiningpharmacokinetics,identifying early pharmacological activity relative to exposure level, assessing observedeffectsonsubsetsof participants,andevaluatingthe therapeuticoutcomesinasmall group of patients suffering from the targeted disease. At this stage of the investigationalproductslifecycle, adrugmayfailsimplybecausethe human participant does not respond to the drug in the same manner that was suggested by preclinical testing. InthisissueofTheAltascientist, weprovideachecklisttohelp youmitigateriskswithastepwise approach to FIH trials.DOWNLOAD YOUR COPYView all issues of The Altascientist.'