Phase I

Phase I trials are the first stage of testing medicines in human subjects. This phase is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are conducted in a clinical center or hospital, where the subjects can be monitored 24/7 by qualified staff.


Also, phase I trials normally include dose-ranging (also called dose escalation studies), to determine the best and safest dose to be administered to patients, and to discover the dose at which a compound becomes too toxic to be administered.