Phase I

Phase I clinical trials are the first stage of testing in human subjects. They are designed to determine the safety and dosage of a new drug or treatment. The trials are usually conducted on a small number of healthy volunteers.

Overview

Phase I trials are the first step in testing a new approach in humans. In these studies, researchers evaluate what dose is safe, how a new agent should be given (by mouth, injected into the blood, or injected into the muscle), and how often. Researchers watch closely for any harmful side effects. Phase I trials are usually conducted in a small number of healthy volunteers.

Purpose

The purpose of Phase I trials is to identify the best way to administer a new treatment and to see what dose is safe. Researchers also look for side effects. Even if the benefits of the new treatment are not clear, the results are used to decide whether to stop testing or move on to Phase II clinical trials.

Process

In a Phase I trial, a small group of people (20-80) is the first to receive the experimental treatment. The doctors start by giving very low doses of the drug to a few participants. If no serious side effects occur, the next group of participants may get a higher dose. This process continues until doctors find a dose that's most likely to work while having an acceptable level of side effects. The exact process can vary based on the goals of the researchers and the type of drug being tested.

Risks and Benefits

Participating in a Phase I trial has potential benefits and risks. The potential benefits include access to new treatments before they are widely available and helping to advance medical research. The risks include side effects and the possibility that the new treatment may not be effective.

See Also

• Phase II clinical trials
• Phase III clinical trials
• Phase IV clinical trials
• Clinical trial

Phase I Resources
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