Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2025-12-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Treatments:

Solutions