Phase I Trials

Phase I trials are the first stage of a research study on human subjects, and they are in place to judge the safety and tolerability of a drug or treatment. Typically done on an inpatient basis, the subject who receives the drug or treatment is observed throughout the process, occasionally overnight trials may occur. Not all Phase I clinical trials in Birmingham include healthy volunteers, some prefer to have patients who have been diagnosed with an ailment that is being studied for investigational treatments.

These Phase I trials are divided into three types: Single Ascending Dose, SAD; Multiple Ascending Dose, MAD; and Food Effect.

Single Ascending Dose studies offer small groups of subjects a single dose and then they are observed and or tested for a specified period of time. If the predicted safe values are shown to be tolerable without and side effects a new group of subjects is chosen. This new group will receive a higher dosage. The process will continue until safety levels or intolerable side effects show up, and when that happens the level is considered to be at a Maximum Tolerated Dose, or MTD.

Multiple Ascending Dose studies are similar to SAD studies but differ because they offer multiple doses of the drug. To understand how the drug is processed in the body, samples of blood and other fluids are collected.

Food Effect studies are designed to understand how the drug interacts with and without food. They usually run as a crossover study in which two identical doses of the drug are given on different occasions; one while fasting, the other while being fed.

Participants in Phase I clinical trials in Alabama are not charged anything, and insurance is not necessary. There is, however, an inconvenience fee for time spent. This payment is based on the period of time.