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Phase I Trials

Phase I clinical trials are the first stage in drug testing on human participants. This phase in the clinical study is where the drug is tested for the first time for safety and dosage ranges, as well as potential toxicity of the new drug. Phase I research is usually operated on an inpatient basis and can last for several months or even years.

Who Participates in Phase I Research?

Phase I clinical trials are conducted with small groups of people, generally ranging from 20 to 100 participants. A stipend is generally given during Phase I trials to compensate volunteers for their time and commitment. Commonly, healthy volunteers such as college students are used for Phase I research; however, there are some rare studies in which actual patients (usually terminally ill) will be used to test very new or toxic drugs for cancer or HIV as a last resort treatment.

Why is Phase I Research Conducted?

Researchers will administer the drug being tested in single doses at the beginning of the Phase I clinical trials. Over the course of the research, doses will be increased and augmented while researchers monitor side effects, absorption rates, toxicity levels and how the drug distributes itself throughout the body. During this time, participants are sequestered for 24-hour periods where they will undergo various tests to identify how the body reacts to the dose-ranging.

Common Questions:

What are Clinical Research Trials?
Why Participate in a Clinical Study?
What’s the difference between a Clinical Trial and Treatment?
Additional Questions for Your Primary Physician

Learn About Clinical Studies:

Florida Clinical Research Resources
Types of Clinical Research Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Clinical Trial Glossary
Clinical Trials History

Understand Your Rights:

Patient Rights
Patient Privacy
Informed Consent
NIH Patient Bill of Rights
Legal, Ethical & Safety Issues