Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which phase of a clinical trial focuses on safety and human pharmacology in healthy volunteers?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase I

Phase I of a clinical trial primarily focuses on assessing the safety and human pharmacology of a treatment in healthy volunteers. This phase is crucial for establishing the appropriate dosage and understanding the pharmacokinetics and pharmacodynamics of the drug. During Phase I trials, researchers observe how the drug behaves in the body, its side effects, and how it is metabolized, which lays the foundation for understanding its effects in later trial phases involving patient populations. Healthy volunteers are used in this phase to minimize the complexities that arise from diseases, allowing researchers to focus solely on the treatment's safety profile. The results obtained here inform the design of subsequent phases, where the drug is tested for efficacy in larger patient populations.