Phase I
From DrugPedia: A Wikipedia for Drug discovery
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Phase 1b studies can include actual patients and might provide first indications about drug efficacy against disease. | Phase 1b studies can include actual patients and might provide first indications about drug efficacy against disease. | ||
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| + | The first Phase 1 study is usually a single-dose study where healthy volunteers receive a range of single doses of the investigational drug. The design and determination of the dose range relies on data such as the maximum tolerated dose (MTD) determined in preclinical animals studies. Vital signs and physiological parameters, such as blood chemistry, are closely monitored in the volunteers and the PK parameters in humans are determined for a single dose. | ||
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| + | The safety and PK data from the single-dose study serve as guide posts for a subsequent multiple-dose study in healthy volunteers, where indicated. | ||
Current revision
The aim of the first clinical trials (phase I) on humans is to help evaluate and understand the behavior of the molecule or compound on healthy subjects.
These studies are designed to determine the pharmacodynamics and pharmacokinetics properties of the compound.These properties help to further design of well controlled scientifically valid Phase-II studies.In Phase I studies, CDER can impose a clinical hold (i.e., prohibit the study from proceeding or stop a trial that has started) for reasons of safety, or because of a sponsor's failure to accurately disclose the risk of study to investigators.
Phase-I testing is divided into two steps.
- Phase 1a
- Phase 1b
Phase 1a studies normally are conducted as a short-term study to ensure safety before embarking on a longer and more comprehensive Phase 1b study.
Phase 1b studies can include actual patients and might provide first indications about drug efficacy against disease.
The first Phase 1 study is usually a single-dose study where healthy volunteers receive a range of single doses of the investigational drug. The design and determination of the dose range relies on data such as the maximum tolerated dose (MTD) determined in preclinical animals studies. Vital signs and physiological parameters, such as blood chemistry, are closely monitored in the volunteers and the PK parameters in humans are determined for a single dose.
The safety and PK data from the single-dose study serve as guide posts for a subsequent multiple-dose study in healthy volunteers, where indicated.
