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

Phase 1 Not yet recruiting 70 enrolled Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

RandomizedSequentialOpen-labelOther

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.

Timeline

Start: 2025-09
Primary completion: 2025-12
Completion: 2025-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluorothiazinone	Unknown	5 ml	Other
Subject	Fluorothiazinone	Unknown	10 ml	Other
Subject	Fluorothiazinone	Unknown	20 ml	Other
Subject	Fluorothiazinone	Unknown	30 ml	Other
Subject	Fluorothiazinone	Unknown	40 ml	Other

Indications

No indication recorded.