Safety and PharmacokineticsPhase 1NCT07184606
Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.
A Phase 1 study testing ¼ of the full (target) dose (solution, 5 ml), ½ of the full (target) dose (solution, 10 ml) and full dose (solution, 20 ml) in people with Safety and Pharmacokinetics, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Pharmacokinetics
- What is being tested?
- ¼ of the full (target) dose (solution, 5 ml), ½ of the full (target) dose (solution, 10 ml) and full dose (solution, 20 ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each potential volunteer for inclusion in the Study should meet all of the following criteria:
- 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.
Show all 35Show fewer
- 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.
- NON-INCLUSION CRITERIA
- 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.
- The volunteer's participation in any other study within the last 90 days.
- Presence of mental illnesses (registered by psychiatric / mental health facility).
- Treatment with steroids in the last 30 days (excluding contraceptives and drugs for intranasal and topical administration).
- Autoimmune diseases or a history of systemic collagenases that require immunosuppressive therapy.
- Volunteers who have undergone organ transplantation, including bone marrow or peripheral blood stem cell transplants.
- Immunosuppressive drugs and/or immunomodulators intake for 6 months prior to the start of the Study.
- Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome [AIDS], etc.).
- Systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg or higher than 90 mmHg; heart rate less than 60 beats / min or more than 100 beats / min.
- Diabetes mellitus or other forms of glucose tolerance disorders.
- The medical history of malignant neoplasms, with the exception of basal cell or squamous cell epithelial skin carcinomas, which were removed without any signs of metastasis for 3 years.
- Blood donation (450 ml or more of blood or plasma) less than 2 months before the start of the Study.
- Taking narcotic and psychostimulant drugs at the present time or according to the anamnesis.
- Drinking alcohol above the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the study drug administration.
- Smoking: more than 10 cigarettes a day.
- Planned hospitalization and / or surgical intervention during the period of participation in the Study, as well as 4 weeks before the expected date of study drug administration.
- Disorders of fat metabolism (pathological hyperlipidemia);
- Pregnancy or breast-feeding.
- The presence of a concomitant disease that may affect the evaluation of the Study results or that, in the opinion of the Investigator, will not allow the volunteer to participate in the Study or may affect the conduct of the study and/or its results (including the assessment of safety parameters), any conditions that, in the opinion of the Investigator (doctor), may be a contraindication to participation in the Study.
Who cannot join
- Volunteers will be excluded from the Study in the following cases:
- Volunteer who does not meet the inclusion criteria and meets at least one exclusion criteria was included in the Study by mistake.
- Severe violation of the Protocol. The volunteer ignored the Protocol requirements, or the volunteer obtained at least one exclusion criteria during participation in the Study, and further participation causes a risk to the volunteer's health.
- 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.
About this study
Official title: Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone (N.F. Gamaleya NRCEM), a Concentrate for Solution Preparation for Infusion With Participation of Adult Healthy Volunteers.
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
- Being tested
- ¼ of the full (target) dose (solution, 5 ml), ½ of the full (target) dose (solution, 10 ml), full dose (solution, 20 ml), 1 ½ of the full (target) dose (solution, 30 ml), 2 full doses (solution, 40 ml)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¼ of the full (target) dose (solution, 5 ml)Drug
- 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).
- 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).
½ of the full (target) dose (solution, 10 ml)Drug
- 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).
- 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).
full dose (solution, 20 ml)Drug
- 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).
- 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).
1 ½ of the full (target) dose (solution, 30 ml)Drug
- 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).
- 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).
2 full doses (solution, 40 ml)Drug
- 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).
- 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).
course administration of the selected doseDrug
10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo.
PlaceboOther
1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: course administration of the selected dose; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AE)
Occurrence of adverse events (AE) according to CTCAE, v.5.0 (Common Terminology Criteria for Adverse Events).
Measured: within 7 days after administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184606
- Sponsor's protocol ID
- 08-FT-2025
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone (N.F. Gamaleya NRCEM), a Concentrate for Solution Preparation for Infusion With Participation of Adult Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT07184606
- Acronym / sponsor ID
- 08-FT-2025
- Conditions
- Safety and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ¼ of the full (target) dose (solution, 5 ml) | Experimental | Drug: ¼ of the full (target) dose (solution, 5 ml), Other: 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. |
| ½ of the full (target) dose (solution, 10 ml) | Experimental | Drug: ½ of the full (target) dose (solution, 10 ml), Other: 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. |
| full dose (solution, 20 ml) | Experimental | Drug: full dose (solution, 20 ml), Other: 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) | Experimental | Drug: 1 ½ of the full (target) dose (solution, 30 ml), Other: 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) | Experimental | Drug: 2 full doses (solution, 40 ml), Other: 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 dose | Experimental | Drug: course administration of the selected dose, Other: Placebo10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (35 listed)
- Each potential volunteer for inclusion in the Study should meet all of the following criteria:
- 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).
Key exclusion criteria (7 listed)
- Volunteer who does not meet the inclusion criteria and meets at least one exclusion criteria was included in the Study by mistake.
- Severe violation of the Protocol. The volunteer ignored the Protocol requirements, or the volunteer obtained at least one exclusion criteria during participation in the Study, and further participation causes a risk to the volunteer's health.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ¼ of the full (target) dose (solution, 5 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 (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 | ½ of the full (target) dose (solution, 10 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 (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 | full dose (solution, 20 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 (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 | 1 ½ of the full (target) dose (solution, 30 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 (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 | 2 full doses (solution, 40 ml) |
| course administration of the selected dose10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo. | Drug | course administration of the selected dose |
| Placebo1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration) | Other | 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) |
Primary outcome
Occurrence of adverse events (AE)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ¼ of the full (target) dose (solution, 5 ml), ½ of the full (target) dose (solution, 10 ml) and full dose (solution, 20 ml) in people with Safety and Pharmacokinetics, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AE) (time frame: within 7 days after administration of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.