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

NCT07184606 | Not Yet Recruiting Phase 1

• 1 other identifier: 08-FT-2025
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Safety and Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events (AE)

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

  within 7 days after administration of the study drug

Study Arms (6)

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

EXPERIMENTAL

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.

Drug: ¼ of the full (target) dose (solution, 5 ml); Other: Placebo

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

EXPERIMENTAL

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.

Drug: ½ of the full (target) dose (solution, 10 ml); Other: Placebo

full dose (solution, 20 ml)

EXPERIMENTAL

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.

Drug: full dose (solution, 20 ml); Other: Placebo

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

EXPERIMENTAL

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.

Drug: 1 ½ of the full (target) dose (solution, 30 ml); Other: Placebo

2 full doses (solution, 40 ml)

EXPERIMENTAL

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.

Drug: 2 full doses (solution, 40 ml); Other: Placebo

course administration of the selected dose

EXPERIMENTAL

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

Drug: course administration of the selected dose; Other: Placebo

Interventions

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

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).

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

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

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).

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

full dose (solution, 20 ml) DRUG

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).

full dose (solution, 20 ml)

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

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).

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

2 full doses (solution, 40 ml) DRUG

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).

2 full doses (solution, 40 ml)

course administration of the selected dose DRUG

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

course administration of the selected dose

Placebo OTHER

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

1 ½ of the full (target) dose (solution, 30 ml); 2 full doses (solution, 40 ml); course administration of the selected dose; full dose (solution, 20 ml); ¼ of the full (target) dose (solution, 5 ml); ½ of the full (target) dose (solution, 10 ml)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written Informed Consent to participate in the Study.
• The ability to understand the requirements for the study participants, and the willingness to follow the procedures provided in the Study Protocol.
• Men and women, age limits: min.: 18, max.: 45.
• Healthy according to the results of a medical examination: no history of pathology in the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, or blood, which may affect the safety of the volunteer and the assessment of the Study results (no diseases or clinically significant abnormalities were revealed by clinical, instrumental, and laboratory tests).
• Negative test results for HIV, hepatitis B and C, syphilis.
• A negative urine test result for presence of narcotic and psychostimulants.
• A negative alcohol content test.
• Indicators of general and biochemical blood analysis at screening in reference interval: 1.1 X Lower limit - 0.9 X Upper limit.
• No contraindications to infusion therapy.
• A negative pregnancy test result.
• Consent to the use effective methods of contraception during the entire period of participation in the Study.
• The potential volunteer will not be included in the Study in the following cases:
• Inability to read in Russian; inability or unwillingness to understand the essence of the Study. Any other condition that restricts the validity of obtaining informed consent or may affect the volunteer's ability to participate in the Study.
• Acute infectious diseases within 2 weeks and non-infectious diseases, exacerbations of chronic diseases within 4 weeks before the screening.
• Hypersensitivity to fish proteins, eggs, soy, peanut butter or the components of the drug SMOFlipid.

You may not qualify if:

• Volunteers will be excluded from the Study in the following cases:
• Follow-up of the volunteer is not possible. The volunteer did not show up for another visit, any attempts to contact the volunteer were unsuccessful. All attempts to contact a volunteer should be documented.
• Voluntary withdrawal from the Study. A volunteer has the right to withdraw from the Study at any time without providing any reasons. If the volunteer provides such reason, it must be registered with the Case Report Form (CRF).
• Investigator's decision that the volunteer should be excluded in the interests of the volunteer himself.
• The development of a serious adverse event before the administration of the study drug.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share