Safety and Pharmacokinetics
Conditions
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.
Interventions
DRUG¼ 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).
DRUG½ 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).
DRUGfull 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).
DRUG1 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).
DRUG2 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).
DRUGcourse administration of the selected dose
10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo.
OTHERPlacebo
1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration)
Sponsors
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Each potential volunteer for inclusion in the Study should meet all of the following criteria: 1. Written Informed Consent to participate in the Study. 2. The ability to understand the requirements for the study participants, and the willingness to follow the procedures provided in the Study Protocol. 3. Men and women, age limits: min.: 18, max.: 45. 4. 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). 5. Negative test results for HIV, hepatitis B and C, syphilis. 6. A negative urine test result for presence of narcotic and psychostimulants. 7. A negative alcohol content test. 8. Indicators of general and biochemical blood analysis at screening in reference interval: 1.1 X Lower limit - 0.9 X Upper limit. 9. No contraindications to infusion therapy. 10. A negative pregnancy test result. 11. 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: 1. 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. 2. Acute infectious diseases within 2 weeks and non-infectious diseases, exacerbations of chronic diseases within 4 weeks before the screening. 3. Hypersensitivity to fish proteins, eggs, soy, peanut butter or the components of the drug SMOFlipid. 4. The volunteer's participation in any other study within the last 90 days. 5. Presence of mental illnesses (registered by psychiatric / mental health facility). 6. Treatment with steroids in the last 30 days (excluding contraceptives and drugs for intranasal and topical administration). 7. Autoimmune diseases or a history of systemic collagenases that require immunosuppressive therapy. 8. Volunteers who have undergone organ transplantation, including bone marrow or peripheral blood stem cell transplants. 9. Immunosuppressive drugs and/or immunomodulators intake for 6 months prior to the start of the Study. 10. Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], etc.). 11. 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. 12. Diabetes mellitus or other forms of glucose tolerance disorders. 13. 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. 14. Blood donation (450 ml or more of blood or plasma) less than 2 months before the start of the Study. 15. Taking narcotic and psychostimulant drugs at the present time or according to the anamnesis. 16. 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. 17. Smoking: more than 10 cigarettes a day. 18. 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. 19. Disorders of fat metabolism (pathological hyperlipidemia); 20. Pregnancy or breast-feeding. 21. 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.
Exclusion criteria
Volunteers will be excluded from the Study in the following cases: 1. Volunteer who does not meet the inclusion criteria and meets at least one
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed