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

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.

Conditions

• Safety and Pharmacokinetics

Interventions

DRUG

¼ of the full (target) dose (solution, 5 ml)

1. st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug (parenteral administration).

DRUG

½ of the full (target) dose (solution, 10 ml)

1. st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug (parenteral administration).

DRUG

full dose (solution, 20 ml)

1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug (parenteral administration).

DRUG

1 ½ of the full (target) dose (solution, 30 ml)

1. st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug (parenteral administration).

DRUG

2 full doses (solution, 40 ml)

1. st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) dose of the study drug (parenteral administration).

DRUG

course administration of the selected dose

10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo.

OTHER

Placebo

1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration)

Sponsors & Collaborators

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

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2025-12-31

Completion

2025-12-31