Safety and Tolerability

The initial study, where first dose is administered in humans, yields valuable information regarding basic pharmacokinetic properties of a new chemical entity, and can give indications about potential nonlinearities in the pharmacokinetics. This safety and tolerability study is usually conducted in healthy adult volunteers, where subjects are administered escalating doses of the drug, starting from low doses that are increased in a stepwise manner. Generally, safety parameters are intensively monitored, and volunteers scheduled for the next dose level are not dosed until a safety evaluation from the previous cohort of subjects is completed. The maximum dose in the study is usually not predetermined, but is limited by adverse events or by predetermined stopping rules. Recommendations of the preclinical toxicological studies that should be completed and evaluated before the first human trial is initiated are described in the ICH Guidance "Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" [2].

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