Phase I Clinical Trials → Study Goals

This is the introduction phase of a drug candidate in humans and it therefore carries the most potential risk. The highest priority is to evaluate the safety of the drug before any other property.

Phase 1 studies are monitored very closely for acute side effects and proper dosing schemes which are typically guided from previous animal studies. Evaluating a drug’s safety profile involves identifying side effects and safe dosage ranges.

During this phase, researchers aim to answer their specific questions set forth in their Clinical Trial Design about how the drug acts in the body and side effects associated with increased dosage, as well as possibly start reporting early signs of how effective the drug candidate is, when applicable. These reports are imperative for designing a Phase II Trial.

Phase I studies may be terminated for a variety of reasons including unfavorable pharmacokinetics, evidence of potential damage to tissues, organs, or cells, or drug-drug interactions.

Approximately 70% of Phase I trials proceed to Phase II.