This is phase I double-blind clinical trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of the study drug given to subjects with mild-moderate dyslipidemia. The study Sponsor is a leading US Biotechnology Company funded by one of Russian investors. In this clinical trial OCT has decided that two sites will be sufficient in order to meet the timelines set forth by the Sponsor. The sites which were selected for this clinical study will be operated and managed in Russia. A maximum number of patients enrolled in this study, depending on the results of the interim analysis, is 54 subjects. OCT plans to enroll all the patients within 4 months. The first cohort of 8 patients has been enrolled and completed treatment. One of the main criteria for this trial was based on the healthy volunteer’s low-density lipoproteins cholesterol (LDL) in order to see if they qualified in the category of Dyslipidemia. A central laboratory located in Europe is used in this trial for safety blood testing.
OCT is very pleased to have been given the opportunity to run this clinical trial for this Sponsor. OCT has good quality experience in this therapeutic area, which is one of the multiple reasons why we were selected to coordinate this clinical trial for this US Biotechnology Sponsor.
This is a full-service support clinical project, including project management, site selection, clinical monitoring, warehousing, central laboratory management, study materials purchase and other logistics assistance, safety management, regulatory activities within the clinical trial approval and export/import licenses obtainment, final report preparation, among other services. In addition OCT provides clinical Data Management in this study.