The first phase serves to assess the safety of the drug in a limited number of people and is an introductory. Usually, during phase I clinical trials, the pharmacokinetic parameters of the drug being tested are studied, metabolism, distribution, excretion and its safety. Also, the purpose of this type of study is to determine the maximum tolerated dose of the drug..

Conducting research

Studies are conducted on healthy volunteers (20-100 Human). During this phase of the clinical trial, volunteers are compensated.

When, if the test drug has a sufficiently 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 relevant disease.