An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone as a Single-Dose Administration or a Treatment Course in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The current Phase I clinical trial has been developed to assess the safety and tolerability
      of the Fluorothyazinone drug used as a single-dose administration and a treatment course in
      healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment
      of volunteers.
    

Detailed description: 
      Based on the screening results of volunteers who signed the Informed Consent Form, the
      volunteers will be sequentially enrolled in three groups to receive different product doses;
      the total number of volunteers receiving the product will be not less than 25 individuals. In
      view of the fact that the product will be studied in humans for the first time, initially 5
      volunteers will be admitted to the hospital to receive a single product dose. As soon as the
      product safety is proven by the follow-up period outcomes on Day 7, the study will be
      continued with the enrollment of additional 5 volunteers. They will receive a single dose of
      600 mg to assess the safety and pharmacokinetics of the studied product.

      After the interim safety assessment on Day 7 is completed, additional 15 volunteers will
      enter the study to receive the product in a dosage regimen proposed for the use in clinical
      practice.

      If necessary, backup individuals (not more than 4) will be additionally enrolled in the
      study. The original volunteers could be replaced only if they had not received the product;
      in case where a volunteer has received the product, no replacement will take place.

      All volunteers will be divided into three groups. Initially, Group I (5 volunteers) will be
      included in the study. As soon as the interim results of safety tests (complete blood count,
      clinical biochemical analysis, clinical urine test and clinical examination of the general
      state of health) obtained on Day 7 are evaluated, the Investigator will make decision on
      whether to enroll the second group (5 individuals) to assess the product used in a dose of
      600 mg. After the interim safety evaluation on Day 7, additional 15 volunteers will enter the
      study to receive the product in a dosage regimen proposed for use in clinical practice.

      Any of the volunteers who received a dose of the studied product will be considered as a
      subject enrolled in the study, and his/her data will be used for assessing the product safety
      and tolerability.

      The consecutive enrollment of volunteers is implied for each of the groups with an interim
      assessment of the safety parameters.

      The study will be composed of four (4) visits for volunteers of Group I (a screening visit,
      the hospitalization visit during which a volunteer will receive the studied product and stay
      for three (3) days at the hospital, and two outpatient visits - 5 and 7 days after receiving
      the product).

      The study will be composed of four (4) visits for volunteers of Group II (a screening visit,
      the hospitalization visit during which a volunteer will receive the studied product and stay
      for seven (7) days at the hospital, and two outpatient visits -14 and 28 days after receiving
      the product).

      The study will be composed of five (5) visits for volunteers of Group III (a screening visit,
      the hospitalization visit during which a volunteer will receive the studied product and stay
      for seven (7) days at the hospital, and three outpatient visits - 14, 28 and 60 days after
      receiving the product).

      After a volunteer signs the Informed Consent Form at the screening stage, a screening number
      will be assigned to the volunteer (consecutive numbering system will be used, i.e. numbers
      will be assigned to volunteers as they arrive: the first volunteer will be assigned a number
      01, the second volunteer - 02, the third - 03, etc.), and appropriate notes will be made in
      the Case Report Forms (CRF) and source documentation.
    

Intervention name(s): Fluorothyazinone 300 mg; Fluorothyazinone 600 mg; Fluorothyazinone 3900 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluorothyazinone in a dosage of 300 mg (1 tablet); Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose; The total dose of Fluorothyazinone per treatment course is 3900 mg.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pseudomanas Aeruginosa; antibiotic resistance; nosocomial infection; factors of pathogenicity of bacteria; the system of secretion of type III pathogenic bacteria; chronic infection