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

Not Applicable
Not yet recruiting
Conditions
Safety and Pharmacokinetics
Interventions
Drug: ¼ of the full (target) dose (solution, 5 ml)
Drug: ½ of the full (target) dose (solution, 10 ml)
Drug: full dose (solution, 20 ml)
Drug: 1 ½ of the full (target) dose (solution, 30 ml)
Drug: 2 full doses (solution, 40 ml)
Drug: course administration of the selected dose
Other: Placebo
Registration Number
NCT07184606
Lead Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
70
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
¼ of the full (target) dose (solution, 5 ml)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. 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.
½ of the full (target) dose (solution, 10 ml)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. 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.
½ of the full (target) dose (solution, 10 ml)Placebo1. 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. 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.
¼ of the full (target) dose (solution, 5 ml)Placebo1. 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. 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.
full dose (solution, 20 ml)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. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug.
full dose (solution, 20 ml)Placebo1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug.
1 ½ of the full (target) dose (solution, 30 ml)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. 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.
1 ½ of the full (target) dose (solution, 30 ml)Placebo1. 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. 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.
2 full doses (solution, 40 ml)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. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug.
2 full doses (solution, 40 ml)Placebo1. st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug.
course administration of the selected dosecourse administration of the selected dose10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo
course administration of the selected dosePlacebo10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo
Primary Outcome Measures
NameTimeMethod
Occurrence of adverse events (AE)within 7 days after administration of the study drug

Occurrence of adverse events (AE) according to CTCAE, v.5.0 (Common Terminology Criteria for Adverse Events).

Secondary Outcome Measures
NameTimeMethod

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