Goals of Phase 1 Testing 1 PREPARATION OF PROTOCOL 2 INITIAL GOALS

. 1 Normal Subjects 2 MEASURE THE PHARMACOLOGICAL IMPACT, to determine the pharmacokinetic behavior and to detect untoward effects. - Sponsor must go back to the animal data to REVIEW EXACTLY WHICH ORGAN SYSTEMS HAVE SHOWN A RESPONSE TO THE DRUG so as to pick out which human systems need to be monitored.