phase 1 (study) phase 1 (study)
The first step in clinical research that gives a new study treatment to a very small group of people, to learn about its safety and effects on the body.
Example of phase 1 (study) in a sentence
A phase 1 study may be researching a study treatment that has not yet been used in humans.
More Info
In a phase 1 study, researchers try to find out how the study treatment interacts with the rest of the body and how the body processes the new study treatment. Phase I studies can also establish how, how much, and how often a study treatment should be given.
In some phase 1 studies, the participants are healthy volunteers.
In cancer research, phase 1 studies include patients with the disease.
Most phase 1 studies will enroll 20 – 100 participants.
Other info to think about when joining a study
The term “phase 1” may be in the protocol or consent form and the study team may use the term when they are talking to you.
You can ask the study team if this new study treatment has been used in human studies before, what information they already have about its safety, and what will happen if there is a safety issue that occurs.
You can ask to learn more about how they plan to monitor you during a phase 1 study.
