Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Phase 1 studies are primarily designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment. In this initial stage of clinical research, the focus is on evaluating how the drug behaves in the body rather than its effectiveness against a particular condition.

Typically, healthy subjects are involved in Phase 1 trials because researchers want to minimize confounding variables that could affect safety and pharmacokinetic data. These participants are often selected to ensure that they do not have underlying health issues that could influence the study's results. This allows for a clearer understanding of how the drug interacts within a body that is not affected by pre-existing conditions.

The use of healthy volunteers helps to establish initial safety profiles and dosages. If the drug demonstrates a favorable safety profile in this phase, further studies may then involve patients with the specific disease the drug intends to treat, which is more common in later phases of clinical trials.