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Phase I study

Phase I study

First-in human studies to test a candidate drug. During the studies, the following is established: tolerability and safety, effect on the main physiological parameters, elimination, absorption and excretion rate constants, peak serum concentration, time necessary to achieve the maximum concentration, metabolism and interaction, half-life period, pharmacokinetic and pharmacodynamic values, protein binding, comparison of dosage forms, area under the “concentration – time” curve (AUC), activity.


  • Development of I phase studies;

  • Development of supporting documents (protocol, investigator’s brochure, patient informed consent, paper and electronic CRF);

  • Selection of a clinical base for a phase I study (Presence of own clinical base (http://certa-clinic.ru) for phase I studies);

  • Insurance of patients participating in phase I studies;

  • Obtaining approvals for a phase I study;

  • Arrangement, monitoring, data management and statistical processing of results of phase I studies;

  • Preparation of a final report for phase I studies;