Clinical trial designed to determine the safety and appropriate dose.
Phase I studies are the first studies conducted in humans, usually in healthy volunteers, as the intention is to collect data on the tolerability, pharmacokinetics and biological effects of the drugs, not to treat disease or illness. Phase I studies with cytotoxic drugs, for e.g. certain anti-cancer drugs, tend to be carried out in patients who have the disease.
an initial study to evaluate the safety of a drug in a single dose in a small group of people.
The first step in human testing of a drug. Tests for safety in humans, and is usually done with a very small number of participants.
The earliest stage clinical trial for studying an experimental drug in humans. Phase I trials are generally comparatively small. They provide an initial evaluation of a drug's safety and pharmacokinetics -- how the drug is absorbed, what tissues it reaches and how long it takes to leave the body. Such studies also usually test various doses of the drug (dose-ranging) to obtain an indication of the appropriate dose to use in later studies.
A phase I clinical trial is done to assess a drugs safety in humans.
The first phase of clinical drug development where the evaluation of a drug is primarily for safety and tolerability in healthy individuals. In one or more clinical trials, safety, tolerability, dose range, and pharmacokinetic profile may be explored
Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
A Phase I vaccine trial is a clinical trial with a small number (usually 60 or less) of healthy volunteers, typically at low-risk for HIV infection. Phase I trials test a vaccine's safety in humans, including its metabolic and pharmacologic actions and any side effects seen with increasing doses.
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
The classification of federally funded trials that test experimental drugs to determine their safety and find the most effective dose.
Testing in healthy volunteers.
A clinical trial in healthy subjects or patients with the primary objective of evaluating the safety and tolerability, and sometimes the pharmacokinetics, of a drug candidate
Testing in very small numbers of individuals to establish a method of administration and safe dose.
A clinical trial primarily designed to examine the safety of an experimental drug and involves 20-100 health volunteers. The various tests used in this phase enable development of the drug's safety profile and the safe dosage range. Further trials cannot take place unless Phase I results show the drug to be reasonably safe when administered to humans.
clinical trials normally conducted in healthy human volunteers following preclinical trials
Studies in healthy subjects to determine biological properties including, pharmacological activity, pharmacokinetics and tolerability of a new drug.
Phase I trials are small trials conducted in healthy volunteers or sometimes in patients. These trials are primarily concerned with determining a drug's safety and possible optimum dose.
The first phase conducted in the complex and multi-faceted drug approval process. Twenty to 80 healthy patients.
clinical trial designed primarily to determine the safety of an experimental drug.
Part of clinical development in which an investigational new drug (IND) is tested on healthy humans in order to test its potential toxicity, its pharmacokinetic properties and its suitable dosage
A Phase I clinical trial is a small-scale test of the safety of a new drug.