A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers.
Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7.
Stage 2 - course administration of the selected dose.
Total number of healthy replacement volunteers: 5.
Written Informed Consent to participate in the Study.
The ability to understand the requirements for the study participants, and the willingness to follow the procedures provided in the Study Protocol.
Men and women, age limits: min.: 18, max.: 45.
Healthy according to the results of a medical examination: no history of pathology in the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, or blood, which may affect the safety of the volunteer and the assessment of the Study results (no diseases or clinically significant abnormalities were revealed by clinical, instrumental, and laboratory tests).
Volunteer who does not meet the inclusion criteria and meets at least one exclusion criteria was included in the Study by mistake.
Severe violation of the Protocol. The volunteer ignored the Protocol requirements, or the volunteer obtained at least one exclusion criteria during participation in the Study, and further participation causes a risk to the volunteer's health.
Follow-up of the volunteer is not possible. The volunteer did not show up for another visit, any attempts to contact the volunteer were unsuccessful. All attempts to contact a volunteer should be documented.
Voluntary withdrawal from the Study. A volunteer has the right to withdraw from the Study at any time without providing any reasons. If the volunteer provides such reason, it must be registered with the Case Report Form (CRF).
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Treatment groupsSee each treatment group below.