Safety, Tolerability, and Pharmacokinetic Parameters of Increasing Doses of Ingavirin Forte, Capsules, During Single and Subsequent Multiple Oral Administration in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Influenza; Viral Respiratory Infection
• Interventions: Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 5 mg; Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 10 mg; Drug: Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 20 mg

• Registration Number: NCT06859333
• Lead Sponsor: Valenta Pharm JSC

Brief Summary

The study of safety, tolerability, and pharmacokinetic parameters of various doses of the drug Ingavirin Forte, capsules, in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. A voluntarily and personally signed informed consent form by a healthy volunteer to participate in the study prior to any study procedures being conducted.
2. Men and women aged 18 to 45 years (inclusive) of Caucasian race.
3. Verified diagnosis of "healthy" (absence of deviations based on clinical, laboratory, and instrumental examination methods specified in the protocol).
4. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).
5. Heart rate (HR) from 60 to 89 beats per minute (inclusive).
6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).
7. Body temperature from 36.0°C to 36.9°C (inclusive).
8. Body mass index (BMI): 18.5 kg/m² ≤ BMI ≤ 30 kg/m², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women.
9. Agreement to use adequate contraceptive methods throughout the study and for 30 days after its completion; for women with preserved reproductive potential, a negative result on a urine pregnancy test is required.

Non-inclusion criteria:

1. Allergic history.
2. Hypersensitivity to imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or excipients included in the study drug in the medical history.
3. Drug intolerance to imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl] diamide of malonic acid (XC9) and/or excipients included in the study drug in the medical history.
4. Hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption in the medical history.
5. Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye.
6. Surgical interventions on the GIT in the medical history (except for appendectomy at least 1 year prior to screening).
7. Diseases/conditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the study drug (SD).
8. Acute infectious diseases less than 4 weeks before screening.
9. Use of drugs that significantly affect hemodynamics, drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), drugs that prolong the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)), less than 2 months before screening.
10. Regular use of drugs less than 2 weeks before screening and single use of drugs less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines).
11. Donating blood or plasma less than 3 months before screening.
12. Use of hormonal contraceptives (in women) less than 2 months before the start of screening.
13. Use of depot injections of any drugs less than 3 months before the start of screening.
14. Pregnancy or lactation; positive urine pregnancy test result for women with preserved reproductive potential.
15. Women with preserved reproductive potential who have had unprotected sexual intercourse within 30 days prior to taking study medications with an unsterilized partner.
16. Participation in another clinical trial less than 3 months prior to screening or concurrently with this study.
17. Consumption of more than 10 units of alcohol per week in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse.
18. Smoking more than 10 cigarettes per day currently or having smoked that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during their stay at the research center.
19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking the study drug.
20. Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort within 7 days prior to taking the study drug.
21. Dehydration due to diarrhea, vomiting or other causes within the last 24 hours before taking the study drug.
22. Positive blood test results for antibodies to human immunodeficiency virus (HIV) types 1 and 2; antibodies to Treponema pallidum antigens; surface antigen of hepatitis B virus (HBsAg); antibodies to hepatitis C virus antigens at screening.
23. Clinically significant deviations on electrocardiogram (ECG) in medical history and/or at screening including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women.
24. Information on risk factors for developing torsades de pointes such as heart failure, hypokalemia, family history of prolonged QT syndrome.
25. Positive urine test for narcotic substances and potent medications at screening.
26. Positive breath alcohol test at screening.
27. Planning hospitalization during the study period for any reason other than hospitalization provided for by this protocol.
28. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, adhere to dietary and activity regimens.
29. Belonging to a vulnerable group of volunteers: students from higher and secondary medical, pharmaceutical and dental educational institutions; junior staff from clinics and laboratories; employees of pharmaceutical companies; military personnel and prisoners; individuals in nursing homes; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or custody; individuals unable to give consent; as well as law enforcement officers.
30. Other conditions that in the investigator's opinion prevent volunteer inclusion in the study or may lead to early withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or a special lifestyle (night work hours, extreme physical exertion).

Exclusion Criteria

1. The volunteer's withdrawal from further participation in the study.
2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of prohibited medications, violation of dietary and lifestyle restrictions, etc.).
3. The emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).
4. Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria.
5. Development of a severe adverse event (SAE) and/or serious adverse reaction (SAR) in the volunteer during the study.
6. The volunteer requires or undergoes treatment that may affect the pharmacokinetics of the study drug.
7. Missing two or more consecutive blood samples or three or more blood samples during one study period.
8. The occurrence of vomiting/diarrhea within 8 hours after taking the study drug.
9. Positive urine test for narcotic substances and potent medications.
10. Positive breath alcohol test result.
11. Positive pregnancy test result in women.
12. The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single and multiple doses, 90 mg + 5 mg	Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 5 mg	Ingavirin Forte, 1 capsule (90 mg + 5 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 5 mg) taken twice a day for 2 days (the first dose under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.
Single and multiple doses, 90 mg + 10 mg	Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 10 mg	Ingavirin Forte, 1 capsule (90 mg + 10 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 10 mg) taken twice a day for 2 days (the first dose on an under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.
Single and multiple doses, 90 mg + 20 mg	Combined preparation of imidazolylethylamide of pentanedioic acid and N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid, 90 mg + 20 mg	Ingavirin Forte, 1 capsule (90 mg + 20 mg) taken once under fasted conditions, followed by Ingavirin Forte, 1 capsule (90 mg + 20 mg) taken twice a day for 2 days (the first dose under fasted conditions, the second dose under fed conditions - 2 hours after a meal), and once in the morning under fasted conditions on the 3rd day. Wash-out period after a single-dose period will last from 7 to 21 days.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics - Cmax	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Maximum plasma concentration (Cmax) of imidazolylethylamide of pentanedioic acid and N,N'-bis-\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\] diamide of malonic acid. The same analytes would be used for other pharmacokinetic measures listed below.
Pharmacokinetics - tmax	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Time to reach Cmax (tmax)
Pharmacokinetics - AUC0-t	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Area under the plasma concentration-time curve from time 0 to t (AUC0-t)
Pharmacokinetics - AUC0-inf	From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose	Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Pharmacokinetics - AUCextr	From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose	Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf
Pharmacokinetics - t1/2	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Elimination half-life (t1/2)
Pharmacokinetics - kel	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Elimination constant (kel)
Pharmacokinetics - MRT	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Mean residence time (MRT)
Pharmacokinetics - Vd	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Volume of distribution
Pharmacokinetics - CL	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Clearance (CL)
Pharmacokinetics - number of terminal timepoints	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)	Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant
Pharmacokinetics - AUC0-tau	From 0 to 48 hours (multiple dose)	Steady state area under the plasma concentration-time curve from time 0 to t (AUC0-tau)
Pharmacokinetics - Cmax,ss	From 0 to 48 hours (multiple dose)	Steady state maximum plasma concentration (Cmax,ss)
Pharmacokinetics - tmax,ss	From 0 to 48 hours (multiple dose)	Steady state time to reach Cmax,ss (tmax,ss)
Pharmacokinetics, urine - Aeinterval	From 48 to 72 hours (multiple dose)	The amount of active substance excreted in urine during each time interval (Aeinterval), calculated as the concentration in urine multiplied by the volume of urine.
Pharmacokinetics, urine - Ae(0-t)	From 48 to 72 hours (multiple dose)	Total urinary excretion from zero to time t (Ae(0-t)), calculated as the sum of the amounts excreted during each time interval
Pharmacokinetics, urine - Rmax	From 48 to 72 hours (multiple dose)	Maximum rate of urinary excretion (Rmax), calculated by dividing the amount of active substance excreted during each time interval by the time over which it was collected
Pharmacokinetics, urine - TRmax	From 48 to 72 hours (multiple dose)	Time of maximum urinary excretion (TRmax), calculated as the average time interval during which Rmax was observed
Pharmacokinetics, urine - Fe0-t	From 48 to 72 hours (multiple dose)	Fraction (% of dose) excreted from the body unchanged (Fe0-t), calculated as Ae/orally administered dose
Pharmacokinetics, urine - CLR	From 48 to 72 hours (multiple dose)	Renal clearance (CLR), calculated as the ratio of Ae(0-t) to AUC(0-t)

Secondary Outcome Measures

Name	Time	Method
Adverse event type	From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)	Adverse events will be assessed by complaints, results of physical examination, results of heart rate and blood pressure assessment, results of respiratory rate assessment, body temperature, laboratory monitoring (clinical blood count, biochemical blood count, urinalysis), electrocardiography; adverse events will be classified in accordance to MedDRA.
Adverse event number	From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)	Number of adverse events registered during the study
Adverse event severety	From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)	Severity of adverse events registered during the study
Drop-outs associated with adverse events	From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)	The number of cases of early termination of participation in the study due to the development of adverse events and/or serious adverse events associated with the study drug
Safety and Tolerability: volunteer complaints	From Day -14 to Day -1 (screening), from Day 1 to Day 21 (single dosing and subsequent wash-out period), from Day 1 to Day 11 (multiple dosing and subsequent observation period)	Description of any health-related complaints received from volunteer
Safety and Tolerability: physical examination results - cardiovascular system	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the cardiovascular system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/cardiovascular symptoms, if any)
Safety and Tolerability: physical examination results - respiratory system	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the respiratory system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/respiratory symptoms, if any)
Safety and Tolerability: physical examination results - digestive tract	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the digestive tract and associated symptoms on physical examination (normal condition or a description of abnormal conditions/digestive tract symptoms, if any)
Safety and Tolerability: physical examination results - endocrine system	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the endocrine system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/endocrine symptoms, if any)
Safety and Tolerability: physical examination results - musculoskeletal system	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the musculoskeletal system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/musculoskeletal symptoms, if any)
Safety and Tolerability: physical examination results - nervous system	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the nervous system and associated symptoms on physical examination (normal condition or a description of abnormal conditions/neurological symptoms, if any)
Safety and Tolerability: physical examination results - sensory systems	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the sensory systems and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any
Safety and Tolerability: physical examination results - skin/visible mucous membranes	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	An assessment of the condition of the skin/visible mucous membranes and associated symptoms on physical examination (normal condition or a description of abnormal conditions/symptoms, if any)
Safety and Tolerability: vital signs - systolic blood pressure	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Systolic blood pressure (SBP, mmHg)
Safety and Tolerability: vital signs - diastolic blood pressure	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Diastolic blood pressure (DBP, mmHg)
Safety and Tolerability: vital signs - heart rate	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Heart rate (HR, bpm)
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Body temperature (Celsius temperature scale)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave; Fredericia correction)
Safety and Tolerability: clinical blood test - hemoglobin	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Hemoglobin (g/L)
Safety and Tolerability: clinical blood test - hematocrit	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Hematocrit (%)
Safety and Tolerability: clinical blood test - red blood cell count	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Red blood cell count (cells/L)
Safety and Tolerability: clinical blood test - platelet count	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Platelet count (cells/L)
Safety and Tolerability: clinical blood test - leukocyte count	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte count (cells/L)
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Erythrocyte sedimentation rate (mm/h)
Safety and Tolerability: clinical blood test - myelocytes	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (myelocytes, %)
Safety and Tolerability: clinical blood test - band neutrophils	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (band neutrophils, %)
Safety and Tolerability: clinical blood test - segmented neutrophils	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (segmented neutrophils, %)
Safety and Tolerability: clinical blood test - eosinophils	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (eosinophils, %)
Safety and Tolerability: clinical blood test - basophils	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (basophils, %)
Safety and Tolerability: clinical blood test - monocytes	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (monocytes, %)
Safety and Tolerability: clinical blood test - lymphocytes	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)	Leukocyte formula (lymphocytes, %)
Safety and Tolerability: urinalysis - specific gravity	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Specific gravity of the urine
Safety and Tolerability: urinalysis - color	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Color of the urine
Safety and Tolerability: urinalysis - transparency	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Transparency of the urine
Safety and Tolerability: urinalysis - pH	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	pH of the urine
Safety and Tolerability: urinalysis - protein	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Protein concentration (g/L)
Safety and Tolerability: urinalysis - glucose	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Glucose concentration (mmol/L)
Safety and Tolerability: urinalysis - red blood cells	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Red blood cell content (number in sight)
Safety and Tolerability: urinalysis - white blood cells	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	White blood cell content (number in sight)
Safety and Tolerability: urinalysis - epithelial cells	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Epithelial cell content (number in sight)
Safety and Tolerability: urinalysis - casts	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Presence of casts (Yes/No)
Safety and Tolerability: urinalysis - mucus	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Presence of mucus (Yes/No)
Safety and Tolerability: urinalysis - bacteria	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Presence of bacteria (Yes/No)
Safety and Tolerability: urinalysis (microscopy)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)	Microscopy of urine sediment is performed if it is present
Safety and Tolerability: blood chemistry - glucose	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Glucose concentration (mmol/L)
Safety and Tolerability: blood chemistry - cholesterol	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Total cholesterol concentration (mmol/L)
Safety and Tolerability: blood chemistry - protein	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Total protein concentration (g/L)
Safety and Tolerability: blood chemistry - creatinine	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Creatinine concentration (micromol/L)
Safety and Tolerability: blood chemistry - bilirubin	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Total bilirubin concentration (micromol/L)
Safety and Tolerability: blood chemistry - alkaline phosphatase	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Alkaline phosphatase activity (U/L)
Safety and Tolerability: blood chemistry - alanine transaminase	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Alanine transaminase activity (U/L)
Safety and Tolerability: blood chemistry - aspartate transaminase	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Aspartate transaminase activity (U/L)
Safety and Tolerability: blood chemistry - potassium concentration	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Potassium (mmol/L)
Safety and Tolerability: blood chemistry - sodium concentration	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Sodium concentration (mmol/L)
Safety and Tolerability: blood chemistry - chloride concentration	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)	Chloride concentration (mmol/L)

Trial Locations

Locations (1)

State Budgetary Healthcare Institution of the City of Moscow "City Clinical Hospital No. 15 named after O.M. Filatov of the Department of Health of Moscow."; 🇷🇺 Moscow, Russian Federation