This is an open-label, single-dose, randomized prospective, single-arm study in healthy volunteers.
The primary objective of the study is to evaluate the safety, tolerability and pharmacokinetics of the anti-tuberculosis drug. The study will be conducted in one investigational site, which will enroll up to 5 volunteer cohorts.
Tuberculosis is a widespread chronic infectious disease which is among the 10 most frequent causes of death all over the world. According to WHO, in 2013 new cases of tuberculosis were found among 9.0 million people, about 1.5 million people died as a result of this disease. Serious anti-tuberculosis programs are being developed to control the disease, but it still remains one of the most common and deadly infections. One of the main reasons why the existing anti-tuberculosis therapy is not effective in some patients is the drug-resistant strains of Mycobacterium tuberculosis, especially multidrug-resistant (MDR) and extensively drug-resistant (XDR) ones. The use of less effective second-line anti-TB therapy require an extremely long period of treatment (up to 24 months), which leads to frequent early termination of anti-TB treatment course. So now all the world medical community recognizes the urgent need to develop new TB drugs and new modes of TB c treatment.
Apart from the full range of services provided by OCT for this study, the company is engaged in development of design for a phase II study in this drug. Over the past two years, OCT has successfully completed a number of projects in this therapeutic area. Having established a strong expertise, our clinical team successfully develops all necessary study documents, obtains regulatory approvals in a timely manner and completes trials within the planned deadlines.