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Phase I Trials

The first stage in testing new and innovative drugs for the use in humans is called Phase I clinical research trials. During this phase of the clinical trial, new drugs are tested for toxicity, dosage and safety for use in humans. Phase I clinical research is conducted on an inpatient basis and can go for a duration of a few months to many years.

Who Participates in Phase I Research?

Small groups of participants are used for Phase I clinical research, usually ranging between 20 to 100 human participants. Participants in Phase I trials typically receive compensation for their time and travel, especially considering the trials are conducted on an inpatient basis. Phase I research uses healthy, college-aged volunteers. Though, there are a few rare studies where terminally ill patients are used test very new and/or toxic for HIV, AIDS, cancer and similar diseases as a last resort treatment.

Why is Phase I Research Conducted?

Single doses of the investigational drug will be given at the inception of a Phase I clinical research study. Throughout the duration of the trial, the dosages will be increased and changed while side effects are monitored. Researchers will also monitor toxicity levels, absorption rates and the distribution pattern of the drug in the human body. Patients are sequestered during this stage for 24-hour periods to undergo various tests related to the dosage changes.

Common Questions:

What is a Clinical Research Trial?
Why Participate in a Clinical Research Trial?
Is there a difference between Clinical Trials and Treatment?

Learn More About Clinical Trials:

What Types of Clinical Trials are Available?
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
Glossary of Clinical Trial Terminology
Alabama Health Resources
Brief History of Clinical Trials
Find Clinical Trials

Know Your Rights as a Participant:

Your Patient Rights
Patient Privacy Rules
Informed Consent Agreement
NIH Patient Bill of Rights
Legal, Ethical, and Safety Issues