Pharmacy Fun Fact: August 21

Which clinical trial phase tests an investigational drug or vaccine on humans for the first time?

Which clinical trial phase tests an investigational drug or vaccine on humans for the first time?

Answer: Phase 1 trials

Phase 1 clinical trials evaluate an investigational drug or vaccine in a small group of human study participants for the first time. The goal of phase 1 studies is to analyze the treatment’s safety, determine a safe dosage range, and identify adverse effects.

REFERENCE

FDA. What are the different types of clinical research? https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research. Last updated January 4, 2018. Accessed August 6, 2020.