Phase I

Phase I trials primarily determine how a new drug works in humans, help to predict the dosage range and involve usually between 50 and 100 healthy volunteers. Phase I trials are short and volunteers are closely monitored at the research center where the trial is being conducted.The principal objective of Phase I trials is to assess what effect the experimental drug has in the human body - what happens to the drug once released in the human body and how the human body reacts to the drug.

The goal of Phase I trials are to:

• Assess the safety of the drug
• Determine the side effects of the drug
• Evaluate how the drug should be administered