PHASE 1 : FIRST IN THE HUMAN STUDY ::
Phase 1 trials are the first -stage of testing in human subjects Normally a small (20-48) group of healthy volunteers will be selected The aim of this phase is to obtain the precise information for the following from the smallest possible number of the patients in a minimum possible time :
(a) Initial efficacy
(b) Initial safety and maximum tolerance
(c) Pharmacokinetics profile of the drug
The trial is carried out usually in healthy human volunteers or patient volunteers phase 1 trials normally include dose-ranging studies so that doses for clinical use can be refined The tested range of doses will usually be a small fraction of the dose that causes harm in animal testing phasc I trials most often include healthy volunteers however there are some circumstances when patients are used such as with oncology (cancer) and HIV drug trials In phase 1 trials of new cancer drugs for example patients with advanced (metastatic) cancer are used These trials are usually offered to patients who have had other types of therapy and who have few if any other treatment choices
There are different kinds of Phase 1 trials :
Single Ascending Dose (SAD) ::
These studies are those in which small groups of patients are given a single dose of the drug while they are observed and tested for a period of time if they do not exhibit any adverse side effects and the pharmacokinetic data is roughly in line with predicted safe values the dose is escalated and a new group of patients is then given a higher dose This is continued until pre -calculated pharmacokinetic safety levels are reached or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)
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