Gamaleya Research Institute Of Epidemiology And Microbiology, Health Ministry Of The Russian Federation

This study is designed to evaluate the safety, clinical efficacy and antibacterial activity of the drug Fluorothiazinone, 300 mg tablets, (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) in the mode of antibacterial monotherapy with the participation of adult patients with chronic bacterial cystitis.
The main objectives of this study are:
1. To evaluate the safety of the use of the drug Fluorothiazinone according to the indicators
1. adverse events/reactions;
2. serious adverse events/reactions;
3. deviations from clinical and laboratory parameters.
2. To evaluate the therapy effectiveness:
1. clinical cure - complete resolution or improvement of the signs and symptoms of chronic cystitis that were present at baseline and the absence of new symptoms requiring antimicrobial therapy on days 7, 14 and 28 after the start of therapy;
2. the timing of the disappearance of symptoms according to the patient's subjective feelings;
3. microbiological response when comparing pre-treatment and post-treatment cultures;
4. changes on VAS (visual analogue scale) for pain intensity determination;
5. changes on PUF (Pelvic pain and urgency/frequency patient symptom scale) for assessing symptoms by patients;
6. changes on ACSS (acute cystitis symptom scale);
7. development of relapses within 90 days after the start of therapy.
3. To collect clinical isolates of pathogens for molecular genetic analysis. The identification of DNA and the determination of the bacterial genotype will allow us to assess the microbiological outcomes such as relapse or reinfection.
4. To determine the sensitivity of the obtained isolates to antibiotics.

Study of the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of the drug B11-FC with a single application in adults

The purpose of the trial is to study the tolerability, safety and pharmacokinetics of the study drug with participation of healthy volunteers after single intravenous administration with dose escalation (0.03 mg/kg, 0.06 mg/kg and 0.12 mg/kg).
Before administration the study drug will be dosed and diluted in 200 ml of isotonic solution of 0.9% sodium chloride, and then will be administered once intravenously via infusion.
During the entire follow-up period, the effect of the study drug on vital signs, instrumental and laboratory data, the development, severity and association of adverse events with the study drug will be monitored, investigated and studied.