Approval obtained for a phase IIa clinical trial in patients with tuberculosis

This is a prospective, open, randomized phase IIa clinical trial with an active control. The trial is aimed to assess the bacterial growth inhibitory activity, safety and pharmacokinetics of the medicinal product in patients newly diagnosed with respiratory tuberculosis.
Tuberculosis is a widespread chronic infectious disease primarily caused by aerobic bacterium M.tuberculosis. The disease is among the leading top 10 causes of death all over the world and remains a major public health problem. According to WHO, in 2013 an estimated 9.0 million people developed tuberculosis and 1.5 million died from the disease. Despite global anti-tuberculosis treatment strategies implemented to control the disease, tuberculosis still remains one of the most common and deadly infections. The global medical community recognizes the urgent need for new anti-tuberculosis medications and new causative treatments against this disease.

The planned duration of the clinical trial is 11 months. 15 investigational sites are expected to participate in the clinical trial. More than 100 men and women between 18-65 years old will be screened and about 50 subjects will be enrolled and randomized into 4 parallel treatment arms. Three treatment arms will be treated with the investigational drug in different dosages, while the forth treatment arm will receive the comparator. The investigational drug represents capsules for oral administration and is intended to be administered as monotherapy for 14 days with no other concomitant treatment allowed during this period. 

The enrollment of the first patients is expected to start in December 2016. In this clinical trial OCT team provides a full service support for the organization and conduct of the phase IIa clinical trial.