Completion of a single-center phase I study of the safety and pharmacokinetics of CPL207280
We have just completed a phase I study of safety and pharmacokinetics (part B) of an innovative therapy that could be used in the treatment of diabetes and metabolic diseases. The product was administered to approximately 32 healthy volunteers as tablets in ascending doses with single administration in the first part of the study and multiple administrations in the double-blind second part.
Due to the global COVID-19 epidemic, the study was conducted using instructions and procedures in line with the guidelines of the Ministry of Health, Sanitary-epidemiological station, WHO (World Health Organization) and EMA (European Medicines Agency).
The tested compound belongs to the newest generation of drugs used in the treatment of diabetes and metabolic diseases. The study confirmed that the drug has a very good safety profile in toxicological and preclinical studies, unlike other drugs in this class. In the case of normal blood glucose levels, the drug does not lower the glucose level, which prevents the occurrence of hypoglycemia.
The results of the study confirmed that the new therapy is effective in regulating blood glucose levels and could be used in the treatment of diseases such as type II diabetes.