Phase I clinical trials

Phase I clinical trials are the first stage of testing in human subjects, designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in healthy subjects. The ultimate goal of Phase I trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacodynamics in order to design well-controlled and scientifically valid Phase II studies.

Overview

Phase I trials are the first step in testing a new drug in humans. In these studies, researchers evaluate what dose is safe, how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), and how often. Researchers closely monitor participants for side effects and to see how the body copes with the drug. Trials are often conducted in healthy subjects.

Purpose

The purpose of Phase I trials is to identify the best way to administer the drug (for example, orally or intravenously), and the best dosage. The drug is tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients.

Process

Phase I trials are characterized by the initial administration of an investigational new drug into humans. These studies are conducted in a small number of healthy subjects and emphasize safety. The goal is to identify side effects and establish a dose-response relationship.

Risks and Benefits

Participation in Phase I trials carries risks, including serious or even life-threatening side effects. However, these trials also offer the potential benefit of access to new treatments before they are widely available.

See Also

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

References

Phase I clinical trials Resources
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