Phase I trial

Phase I trial is the first stage in the clinical trial process that is used to test new medical treatments or drugs. This phase primarily focuses on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment.

Overview

Phase I trials are usually the first studies in humans and are typically conducted in a small number of healthy volunteers. The main aim of these trials is to determine the safety and tolerability of the new drug or treatment, as well as to understand its effects on the human body. This includes how it is absorbed, metabolized, and excreted.

Objectives

The primary objectives of a Phase I trial are to:

• Evaluate the safety and tolerability of the drug or treatment
• Determine the dosage range for the drug
• Identify any side effects
• Understand how the drug is metabolized and excreted

Process

Phase I trials are typically conducted in a controlled, inpatient setting where volunteers can be closely monitored. The trial begins with a small dose of the drug or treatment, which is gradually increased in subsequent groups of volunteers until the maximum tolerated dose is identified.

Risks and Benefits

Participation in a Phase I trial carries both potential risks and benefits. The main risk is that the new drug or treatment may have unexpected side effects. However, participants also have the opportunity to contribute to the development of new treatments and may potentially benefit from the drug or treatment being studied.

See Also

• Clinical trial
• Phase II trial
• Phase III trial
• Drug development

Phase I trial Resources
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