Phase i clinical trial
phase I clinical trial
(Science: pharmacology) The earliest stage clinical trial for studying an experimental drug in humans. Phase I trials are generally comparatively small and are used to determine toxicity and maximum dose.
They provide an initial evaluation of a drug's safety and pharmacokinetics-how the drug is absorbed, what tissues it reaches and how long it takes to leave the body. Such studies also usually test various doses of the drug (dose-ranging) to obtain an indication of the appropriate dose to use in later studies.
The patients in these trials usually have advanced disease and have already received best available chemotherapy, therefore, seeing a repose is significant partially because this means there is a lack of cross-resistance between two anti-cancer drugs.