Definitions for "PHASE I CLINICAL TRIAL"
Related Terms:
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A trial designed primarily to evaluate toxicity of a new therapeutic agent and to determine the maximal 'safe' dose.
A study conducted in healthy subjects to determine the biological effects of a drug, especially safety and tolerability
a clinical study that examines the new drug's safety profile and usually involves 10 to 60 healthy volunteers.
a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
a small-scale test of the safety of a new drug
the first stage in testing new drugs or vaccines in humans. Phase I trials are performed on small numbers of people and are designed primarily to test the safety of the new drug and to obtain information about dosages. Drugs that pass phase I trials go on to trials that determine effectiveness and possible side effects and are tested on larger groups of people. If safety and effectiveness are demonstrated, the drugs or vaccines may become approved as treatments.
A clinical trial of a vaccine conducted in a small number of healthy volunteers. A Phase I is designed to determine the vaccine's safety and immunogenicity in humans, its metabolism and pharmacologic actions, and side effects associated with increasing doses.
a test in healthy human volunteers to test the safety and tolerability of a drug
The assessment of the safety of a biologically active substance in volunteers
The earliest stage of a trial for studying a new therapy. Phase I trials are generally small. They provide an initial evaluation of the safety of the therapy and, depending on the therapy, preliminary indications of dosage, duration and other basic information for use in later studies.
the first clinical trial of an experimental drug, desined to evaluate toxicity (adverse reactions) at various dosing levels. Most phase one clinical trials have only a small number participants. Phase I clinical trials are part of the U.S. FDA approval process. (also see double-blind, and open label trial.)
an experiment designed to evaluate adverse reactions, optimal dose, and best route of administration.
"The initial set of drug studies in humans, which are generally designed to evaluate the safety of a new drug in a small number of patients or normal volunteers."
A phase 1 study is designed to find out: • what is the most effective dose of the drug and how much can be given safely, for example the maximum dose and how often the drug can be given • whether enough of the drug is circulating in the blood to kill cancer cells • the side effects of the drug.