CITI Training Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

Question: 1 / 400

Which trial phase enrolls normal healthy volunteers unless the toxicity of the drug prevents such exposure?

Phase I

Phase I is the first stage of clinical trials where the safety and dosage of a new drug is tested on a small group of healthy volunteers. The purpose of phase I is to determine the maximum safe dose of the drug and potential side effects. Phase II and III trials involve testing the drug on larger groups of people with the target disease or condition, making it a less suitable option for enrolling normal healthy volunteers. Phase IV trials are conducted after the drug has been approved and are used to gather additional information on the safety and effectiveness of the drug. Therefore, phase I is the only option that specifically enrolls normal healthy volunteers. The other options have different objectives and target populations, making them incorrect choices.

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Phase II

Phase III

Phase IV

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