Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

An Open-label Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers

This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.

Study Overview

• Status: Recruiting
• Conditions: Influenza; Viral Respiratory Infection
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • 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."
    • Contact: Ivan Gordeev; Phone Number: +7495-918-72-84; Email: cardio-15@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Signed informed consent form by the healthy subject prior to any study activities.
2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.
3. Verified "healthy" diagnosis (no abnormalities detected 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 of childbearing potential - a negative urine pregnancy test result.

Non-inclusion criteria:

1. Known 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.
4. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
5. Evidence or history of chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic and vision organs.
6. History of GIT surgery (except for appendectomy at least 1 year prior to screening).
7. Diseases/conditions that, in the judgment of the investigator, 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. Blood or plasma donation within 3 months before screening.
12. Use of hormonal contraceptives (in women) within 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 for women of childbearing potential.
15. Women of childbearing 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 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 test for alcohol vapors 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 judgment of the investigator, may interfere with participation in the study or may lead to early withdrawal of the volunteer 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 test for alcohol vapors.
11. Positive pregnancy test in female participants.
12. The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single and multiple doses, 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.	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; Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 5 mg of N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid
Experimental: Single and multiple doses, 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.	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; Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 10 mg of N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid
Experimental: Single and multiple doses, 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.	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; Capsules, containing 90 mg of imidazolylethylamide of pentanedioic acid and 20 mg of N,N'-bis-[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl] diamide of malonic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics - Cmax	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.	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - tmax	Time to reach Cmax (tmax)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - AUC0-t	Area under the plasma concentration-time curve from time 0 to t (AUC0-t)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - AUC0-inf	Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)	From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose
Pharmacokinetics - AUCextr	Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf	From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose
Pharmacokinetics - t1/2	Elimination half-life (t1/2)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - kel	Elimination constant (kel)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - MRT	Mean residence time (MRT)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - Vd	Volume of distribution	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - CL	Clearance (CL)	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - number of terminal timepoints	Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant	From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
Pharmacokinetics - AUC0-tau	Steady state area under the plasma concentration-time curve from time 0 to t (AUC0-tau)	From 0 to 48 hours (multiple dose)
Pharmacokinetics - Cmax,ss	Steady state maximum plasma concentration (Cmax,ss)	From 0 to 48 hours (multiple dose)
Pharmacokinetics - tmax,ss	Steady state time to reach Cmax,ss (tmax,ss)	From 0 to 48 hours (multiple dose)
Pharmacokinetics, urine - Aeinterval	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.	From 48 to 72 hours (multiple dose)
Pharmacokinetics, urine - Ae(0-t)	Total urinary excretion from zero to time t (Ae(0-t)), calculated as the sum of the amounts excreted during each time interval	From 48 to 72 hours (multiple dose)
Pharmacokinetics, urine - Rmax	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	From 48 to 72 hours (multiple dose)
Pharmacokinetics, urine - TRmax	Time of maximum urinary excretion (TRmax), calculated as the average time interval during which Rmax was observed	From 48 to 72 hours (multiple dose)
Pharmacokinetics, urine - Fe0-t	Fraction (% of dose) excreted from the body unchanged (Fe0-t), calculated as Ae/orally administered dose	From 48 to 72 hours (multiple dose)
Pharmacokinetics, urine - CLR	Renal clearance (CLR), calculated as the ratio of Ae(0-t) to AUC(0-t)	From 48 to 72 hours (multiple dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event type	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.	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 event severety	Severity of adverse events registered during the study	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)
Drop-outs associated with adverse events	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	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 event number	Number of adverse events registered during the study	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)
Safety and Tolerability: volunteer complaints	Description of any health-related complaints received from volunteer	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)
Safety and Tolerability: physical examination results - cardiovascular system	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - respiratory system	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - digestive tract	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - endocrine system	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - musculoskeletal system	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - nervous system	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - sensory systems	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	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: physical examination results - skin/visible mucous membranes	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)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: vital signs - systolic blood pressure	Systolic blood pressure (SBP, mmHg)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: vital signs - diastolic blood pressure	Diastolic blood pressure (DBP, mmHg)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: vital signs - heart rate	Heart rate (HR, bpm)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)	Body temperature (Celsius temperature scale)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate	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)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval	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)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex	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)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval	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)	Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - hemoglobin	Hemoglobin (g/L)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - hematocrit	Hematocrit (%)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - red blood cell count	Red blood cell count (cells/L)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - platelet count	Platelet count (cells/L)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - leukocyte count	Leukocyte count (cells/L)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate	Erythrocyte sedimentation rate (mm/h)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - myelocytes	Leukocyte formula (myelocytes, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - band neutrophils	Leukocyte formula (band neutrophils, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - segmented neutrophils	Leukocyte formula (segmented neutrophils, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - eosinophils	Leukocyte formula (eosinophils, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - basophils	Leukocyte formula (basophils, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - monocytes	Leukocyte formula (monocytes, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: clinical blood test - lymphocytes	Leukocyte formula (lymphocytes, %)	Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - specific gravity	Specific gravity of the urine	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - color	Color of the urine	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - transparency	Transparency of the urine	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - pH	pH of the urine	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - protein	Protein concentration (g/L)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - glucose	Glucose concentration (mmol/L)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - red blood cells	Red blood cell content (number in sight)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - white blood cells	White blood cell content (number in sight)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - epithelial cells	Epithelial cell content (number in sight)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - casts	Presence of casts (Yes/No)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - mucus	Presence of mucus (Yes/No)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis - bacteria	Presence of bacteria (Yes/No)	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: urinalysis (microscopy)	Microscopy of urine sediment is performed if it is present	Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - glucose	Glucose concentration (mmol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - cholesterol	Total cholesterol concentration (mmol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - protein	Total protein concentration (g/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - bilirubin	Total bilirubin concentration (micromol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - creatinine	Creatinine concentration (micromol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - alkaline phosphatase	Alkaline phosphatase activity (U/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - alanine transaminase	Alanine transaminase activity (U/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - aspartate transaminase	Aspartate transaminase activity (U/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - potassium concentration	Potassium (mmol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - sodium concentration	Sodium concentration (mmol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)
Safety and Tolerability: blood chemistry - chloride concentration	Chloride concentration (mmol/L)	Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: IFR-01-01-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No