Initial testing in a small group of humans to determine safety, dosing and identify side effects associated with an investigational drug.
Clinical trial conducted to find the safest dose and most effective way to give a new cancer treatment to patients, as well as identify potential side effects. Phase I trials are usually limited to a small number of patients who would not be helped by other known treatments.
A clinical trial to study the pharmacology of an investigational medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
a design to determine the safety of the new drug that has not before been given to a patient
a dose finding study where the primary objective is to determine the Maximum Tolerated Dose (MTD) of the treatment and to define the toxcities of the treatment
a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely
an in-depth study in which a small number of volunteers are used to test dosage, effect, duration of effect and side effects of a drug or device
a research study using techniques, or products for the first time in human subjects)
a small-scale test in healthy volunteers to determine the general safety of the treatment with human subjects
Small groups of people with cancer are treated with a certain dose of a new agent that has already been extensively studied in the laboratory. During the trial, the dose is usually increased group by group in order to find the highest dose that does not cause harmful side effects. This process determines a safe and appropriate dose to use in a phase II trial. Usually does not include a control treatment for comparison.
Phase I trials test the safety and tolerability of new products in small numbers of healthy volunteers who are not at risk for disease. Studies are initiated with low doses and, if these are safe, proceed to test higher doses.
an early clinical trial designed to study an experimental vaccine in humans. Phase I trials are generally small (less than 100 participants) and designed to see if the product is safe.
the first stage of human testing of a new drug. Phase I trials evaluate drug pharmacokinetics, safety and toxicity at different dose levels, typically in a small number (less than 100) of healthy volunteers.
The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
The first stage in testing a new drug in humans. The studies are usually done to gather preliminary information on the chemical action, dosage and safety of the drug using healthy volunteers. Usually done without a comparison group.
Initial introduction of an investigational new drug into humans. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
A clinical trial that serves as the initial introduction of an investigational new drug into humans. Phase I trials test physiologic factors, toxicity, and appropriate dosage. . A Phase I trial often enrolls only a small number of patients.
tests a substance in a limited number of healthy people to learn whether it is safe to take and what happens when it enters the body.
Trial to determine the safety of a therapy or combination therapy not previously used in treating humans. Cf: in vitreo, in vitro, in vivo. Phase I trials typically enroll patients in cohorts, with each successive cohort receiving an increasing dose of the investigational therapy until dose limiting toxicity (DLT) is observed in a defined number of patients. The dosage level below the level of DLT is then defined as the maximum tolerated dose (MTD). Patients enrolled in Phase I trials have disease which is refractory to standard therapies, and usually only evaluable disease is required.
Study of a small group of patients to determine the side effects of a new treatment, with escalating intensity of the treatment administered.
Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give a new treatment (for example, by mouth, IV drip, or injection), and the best dose. The drug is usually given in progressively higher doses to determine the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of treatments being tested, phase I trials usually include only a limited number of patients who have not been helped by other known treatments.