TSXV:CLAS.H - Post by User
Post by
Red~Oneon Mar 05, 2022 7:42pm
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Post# 34487426
Phase I Trials
Phase I TrialsTest if a new treatment is safe in people. Doctors also find the best way to give the treatment. The goal of a Phase I trial is to:
- Find out if a new treatment is safe.
- Find the best way to give the new treatment, such as by mouth or by vein.
Phase I trials usually include 15 to 30 patients who are divided into small groups. These groups are called cohorts. The first cohort receives a dose of the new drug. Doctors may collect blood or urine samples to measure drug levels in the patients.
If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the doctors find the best dose for future testing. With each increasing dose, doctors test each patient to see if he or she is responding to the treatment. If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.