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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Study First Submitted
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
(from sponsor)		 Safety and Pharmacokinetics
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov