Phase 1 clinical trials

Objective: Phase I clinical trials consist in studying tolerance to new dru gs 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 m etabolic and excretory pathways involved in the human organism. Implementation: Phase I trials are conducted in healthy volunteer men and w omen. An exception is made for drugs with predictable toxic effects, for ex ample anti-cancer drugs, which cannot be tested in healthy subjects. These trials are controlled by legal regulations clearly defined in the French la w of December 20, 1988. Contribution: Data collected from Phase I trails in humans are crucial for initialing phase II and III drug development trials to be conducted in pati ents and designed to obtain a satisfactory assessment of the new drug's ris k/benefit ratio.