The first phase serves to assess the safety of the drug in a limited number of people and is an introductory one. Typically, during Phase I of Clinical studies, pharmacokinetic parameters of the test drug, metabolism, distribution, drug clearance and its safety are studied. Also the purpose of this type of research is to determine the maximum tolerated dose of the drug.
Conducting of the study
The study is conducted on healthy volunteers (20 – 100 people). During this phase of Clinical studies volunteers receive payment.
If the test drug has rather high toxicity (for example, for the treatment of cancer), conducting such studies on healthy volunteers is unethical. In such cases, studies are conducted on patients with the corresponding disease.