Clinical Trial

Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.

Not Yet Recruiting Phase 1
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Record status
This record was last updated September 22, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07184606
Lead Sponsor Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions Safety and Pharmacokinetics
Enrollment 70 participants
Start Date 2025-09
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-22