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Phase I

Phase I trials primarily determine how a new drug works in humans, help to predict the dosage range and involve between fifty and one hundred healthy volunteers. Phase I trials are short and volunteers are closely monitored at the research centre 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 goals of Phase I trials are:

  • To assess the safety of the drug,
  • To determine the side effects of the drug,
  • To evaluate how the drug should be administered