Phase I Clinical Trials

What Is a Phase I Clinical Trial?

Phase I Clinical Trials involve testing of the new drug for the first time in humans to a small group (20-100) of healthy volunteers or people with the disease/condition of interest to evaluate the drug candidate’s safety. While preclinical research answers basic questions about a drug’s safety and pharmacokinetic profile, it is not a substitute for studying these aspects in the human body. A “clinical trial” refers to testing of a drug compound in humans.

Learning Objectives

• Discuss the primary purpose of Phase I in clinical trials
• Describe how a clinical trial is designed
• Identify the clinical trial design for Phase I studies