[Phase I clinical trials].
OBJECTIVE
Phase I clinical trials consist in studying tolerance to new drugs administered for the first time to humans, the pharmacodynamics of these drugs in order to describing as clearly as possible their pharmacological mechanism of action, and their pharmacokinetics in order to determine the metabolic and excretory pathways involved in the human organism.


METHODS
Phase I trials are conducted in healthy volunteer men and women. An exception is made for drugs with predictable toxic effects, for example anti-cancer drugs, which cannot be tested in healthy subjects. These trials are controlled by legal regulations clearly defined in the French law of December 20, 1988.
Data collected from Phase I trails in humans are crucial for initiating phase II and III drug development trials to be conducted in patients and designed to obtain a satisfactory assessment of the new drug's risk/benefit ratio.
Jaillon
P
P
Service de Pharmacologie, Faculté de Médecine Saint-Antoine, 27, rue de Chaligny, F75571 Paris.
D000970:Antineoplastic Agents / Q000009:adverse effects*; D017321:Clinical Trials, Phase I as Topic; D003625:Data Collection; D006801:Humans; D012107:Research Design
D000970:Antineoplastic Agents