Certified Clinical Research Associate (CCRA) Practice Exam

Phase 1 studies are primarily focused on evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment in humans. During this initial phase, the goal is to determine how the drug behaves in the body, including how it is absorbed, distributed, metabolized, and excreted.

Typically, Phase 1 clinical trials involve a small group of healthy volunteers, commonly ranging from 20 to 80 participants. This number allows researchers to gather preliminary safety data and monitor for adverse effects in a controlled environment. The relatively small size is suitable for determining initial dosing and safety profiles without exposing too many individuals to the investigational drug.

As a result, the choice indicating that 20 to 80 volunteers typically participate in Phase 1 studies aligns well with the standard practices in clinical research regarding patient safety and data collection during this crucial first step in testing new therapies.