Phase I Clinical Trial

Definition

Phase I clinical trials are often the first time a potential new medication is given to humans. They are conducted following extensive animal testing for both efficacy and safety. Typically, healthy paid volunteers are administered progressively higher doses in the same session or, more commonly, over several sessions. These sessions are conducted in specialized laboratories equipped and staffed to monitor carefully the subject’s physiological and behavioral response. In most phase I trials, plasma samples are taken to measure levels of the drug and its metabolites to determine rates of metabolism and elimination and develop a pharmacokinetic model of the drug’s biodisposition.

Cross-References

• Abuse Liability Evaluation

• Phase II Clinical Trial

• Phase III Clinical Trial

• Randomized Controlled Trials