definiens: shalllmeanclinical trialsinhealthy adultsand / orinasmallnumber ofpatients commencing uponthefilingofatrialprotocol withtheappropriateregulatory bodyanddesigned todetermine themetabolism andpharmacologic actions ofaproduct inhumans, thesideeffects associated withincreasing dosesandtogatherevidence oneffectiveness andmeeting therequirements established bytheFDAorbytheequivalentJapanese agency forPhaseIclinical trials . Thecompletion ofthePhaseIClinical Trialswillbedeemed tohaveoccurred uponthefirstformal internal issuance oftrialresults asmeasured bytrialobjectives, orinanyeventnolaterthanthecommencement ofthePhaseIIClinical Trials