The innovative drug is a novel and promising oral anti-tuberculosis drug candidate. This product is currently at the final stage of preclinical development. Comprehensive toxicity studies (acute, sub-chronic and chronic toxicity) confirmed its low toxicity. Moreover, it has been reported in animal experiments that the drug did not affect the immune system and showed no allergic, genotoxic or carcinogenic action.
Thus, due to its potentially high efficiency and expected favorable safety, it was decided to conduct an open-label, prospective, non-comparative clinical trial to assess the safety, tolerability and pharmacokinetic profile of the drug in healthy volunteers after single increasing doses (as the first stage of the clinical development of the medicinal product). The follow-up period will be less than a month.
This is a full-service clinical project in which OCT will be engaged in elaboration and implementation of a preclinical study program, development of phase I clinical trial design, preparation of Investigator’s Brochure, clinical trial protocol and all essential documents, as well as site selection, logistics, clinical monitoring and data management, preparation of interim and final reports. This project implies the development of designs for possible additional phase I and II clinical trials. OCT team is currently engaged in developing a strategy for future clinical trials required for marketing authorization of the drug.