AzTrials
AzTrials

InfluenzaPhase 1NCT06859333

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

A Phase 1 study testing 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, 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 and 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 in people with Influenza and Viral Respiratory Infection, run by Valenta Pharm JSC at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Viral Respiratory Infection
What is being tested?
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, 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 and 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteRussia
Study dates
13 Jan 2025to 31 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

  • Signed informed consent form by the healthy subject prior to any study activities.
  • Males and females aged 18 to 45 years (inclusive) of Caucasian race.
  • Verified "healthy" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).
  • 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).
  • Heart rate (HR) from 60 to 89 beats per minute (inclusive).
  • Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).
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  • Body temperature from 36.0°C to 36.9°C (inclusive).
  • 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.
  • 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:
  • Known allergic history.
  • 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.
  • 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.
  • Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
  • 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.
  • History of GIT surgery (except for appendectomy at least 1 year prior to screening).
  • Diseases/conditions that, in the judgment of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (SD).
  • Acute infectious diseases less than 4 weeks before screening.
  • 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.
  • 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).
  • Blood or plasma donation within 3 months before screening.
  • Use of hormonal contraceptives (in women) within 2 months before the start of screening.
  • Use of depot injections of any drugs less than 3 months before the start of screening.
  • Pregnancy or lactation; positive urine pregnancy test for women of childbearing potential.
  • Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to taking study medications with an unsterilized partner.
  • Participation in another clinical trial less than 3 months prior to screening or concurrently with this study.
  • 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.
  • 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.
  • Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking the study drug.
  • 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.
  • Dehydration due to diarrhea, vomiting or other causes within the last 24 hours before taking the study drug.
  • 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.
  • 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.
  • Information on risk factors for developing torsades de pointes such as heart failure, hypokalemia, family history of prolonged QT syndrome.
  • Positive urine test for narcotic substances and potent medications at screening.
  • Positive test for alcohol vapors at screening.
  • Planning hospitalization during the study period for any reason other than hospitalization provided for by this protocol.
  • Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, adhere to dietary and activity regimens.
  • 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.
  • 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).

Who cannot join

  • The volunteer's withdrawal from further participation in the study.
  • 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.).
  • The emergence of reasons/situations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).
  • Volunteers selected for participation in the study who do not meet inclusion/exclusion criteria.
  • Development of a severe adverse event (SAE) and/or serious adverse reaction (SAR) in the volunteer during the study.
  • The volunteer requires or undergoes treatment that may affect the pharmacokinetics of the study drug.
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  • Missing two or more consecutive blood samples or three or more blood samples during one study period.
  • The occurrence of vomiting/diarrhea within 8 hours after taking the study drug.
  • Positive urine test for narcotic substances and potent medications.
  • Positive test for alcohol vapors.
  • Positive pregnancy test in female participants.
  • The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Russia1 site, 1 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."

    Moscow

    Ivan Gordeev, +7495-918-72-84, cardio-15@yandex.ru

    Recruiting

Other trials in Russia

About this study

Official title: 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.

Being tested
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, 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, 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
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 mgDrug

    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

  • 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 mgDrug

    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

  • 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 mgDrug

    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

Study groups in NCT06859333
Study groupRoleWhat they receive
Single and multiple doses, 90 mg + 5 mgExperimentalIngavirin 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.
Receives: 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
Single and multiple doses, 90 mg + 10 mgExperimentalIngavirin 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.
Receives: 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
Single and multiple doses, 90 mg + 20 mgExperimentalIngavirin 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  2. Pharmacokinetics - tmax

    Time to reach Cmax (tmax)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  3. Pharmacokinetics - AUC0-t

    Area under the plasma concentration-time curve from time 0 to t (AUC0-t)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  4. Pharmacokinetics - AUC0-inf

    Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

  5. Pharmacokinetics - AUCextr

    Extrapolated AUC defined as (AUC0-inf - AUC0-t)/AUC0-inf

    Measured: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose

  6. Pharmacokinetics - t1/2

    Elimination half-life (t1/2)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  7. Pharmacokinetics - kel

    Elimination constant (kel)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  8. Pharmacokinetics - MRT

    Mean residence time (MRT)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  9. Pharmacokinetics - Vd

    Volume of distribution

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  10. Pharmacokinetics - CL

    Clearance (CL)

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  11. Pharmacokinetics - number of terminal timepoints

    Number of points in the terminal logarithmic phase used to estimate the terminal elimination rate constant

    Measured: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)

  12. Pharmacokinetics - AUC0-tau

    Steady state area under the plasma concentration-time curve from time 0 to t (AUC0-tau)

    Measured: From 0 to 48 hours (multiple dose)

  13. Pharmacokinetics - Cmax,ss

    Steady state maximum plasma concentration (Cmax,ss)

    Measured: From 0 to 48 hours (multiple dose)

  14. Pharmacokinetics - tmax,ss

    Steady state time to reach Cmax,ss (tmax,ss)

    Measured: From 0 to 48 hours (multiple dose)

  15. 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.

    Measured: From 48 to 72 hours (multiple dose)

  16. 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

    Measured: From 48 to 72 hours (multiple dose)

  17. 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

    Measured: From 48 to 72 hours (multiple dose)

  18. Pharmacokinetics, urine - TRmax

    Time of maximum urinary excretion (TRmax), calculated as the average time interval during which Rmax was observed

    Measured: From 48 to 72 hours (multiple dose)

  19. Pharmacokinetics, urine - Fe0-t

    Fraction (% of dose) excreted from the body unchanged (Fe0-t), calculated as Ae/orally administered dose

    Measured: From 48 to 72 hours (multiple dose)

  20. Pharmacokinetics, urine - CLR

    Renal clearance (CLR), calculated as the ratio of Ae(0-t) to AUC(0-t)

    Measured: From 48 to 72 hours (multiple dose)

Secondary outcomes (58)

  1. 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.

    Measured: 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)

  2. Adverse event number

    Number of adverse events registered during the study

    Measured: 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)

  3. Adverse event severety

    Severity of adverse events registered during the study

    Measured: 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)

  4. 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

    Measured: 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)

  5. Safety and Tolerability: volunteer complaints

    Description of any health-related complaints received from volunteer

    Measured: 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)

  6. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  7. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  8. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  9. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  10. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  11. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  12. 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

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  13. 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)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  14. Safety and Tolerability: vital signs - systolic blood pressure

    Systolic blood pressure (SBP, mmHg)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  15. Safety and Tolerability: vital signs - diastolic blood pressure

    Diastolic blood pressure (DBP, mmHg)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  16. Safety and Tolerability: vital signs - heart rate

    Heart rate (HR, bpm)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  17. Safety and Tolerability: vital signs - body temperature (Celsius temperature scale)

    Body temperature (Celsius temperature scale)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  18. 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)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  19. 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)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  20. 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)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  21. 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)

    Measured: Screening, Day 1 to 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  22. Safety and Tolerability: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  23. Safety and Tolerability: clinical blood test - hematocrit

    Hematocrit (%)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  24. Safety and Tolerability: clinical blood test - red blood cell count

    Red blood cell count (cells/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  25. Safety and Tolerability: clinical blood test - platelet count

    Platelet count (cells/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  26. Safety and Tolerability: clinical blood test - leukocyte count

    Leukocyte count (cells/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  27. Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate (mm/h)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  28. Safety and Tolerability: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  29. Safety and Tolerability: clinical blood test - band neutrophils

    Leukocyte formula (band neutrophils, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  30. Safety and Tolerability: clinical blood test - segmented neutrophils

    Leukocyte formula (segmented neutrophils, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  31. Safety and Tolerability: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  32. Safety and Tolerability: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  33. Safety and Tolerability: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  34. Safety and Tolerability: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1, 3, 4, 11 (multiple dosing)

  35. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  36. Safety and Tolerability: urinalysis - color

    Color of the urine

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  37. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  38. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  39. Safety and Tolerability: urinalysis - protein

    Protein concentration (g/L)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  40. Safety and Tolerability: urinalysis - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  41. Safety and Tolerability: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  42. Safety and Tolerability: urinalysis - white blood cells

    White blood cell content (number in sight)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  43. Safety and Tolerability: urinalysis - epithelial cells

    Epithelial cell content (number in sight)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  44. Safety and Tolerability: urinalysis - casts

    Presence of casts (Yes/No)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  45. Safety and Tolerability: urinalysis - mucus

    Presence of mucus (Yes/No)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  46. Safety and Tolerability: urinalysis - bacteria

    Presence of bacteria (Yes/No)

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  47. Safety and Tolerability: urinalysis (microscopy)

    Microscopy of urine sediment is performed if it is present

    Measured: Screening, Day 2 (single dosing), Day 4, 11 (multiple dosing)

  48. Safety and Tolerability: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  49. Safety and Tolerability: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  50. Safety and Tolerability: blood chemistry - protein

    Total protein concentration (g/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  51. Safety and Tolerability: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  52. Safety and Tolerability: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  53. Safety and Tolerability: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  54. Safety and Tolerability: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  55. Safety and Tolerability: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  56. Safety and Tolerability: blood chemistry - potassium concentration

    Potassium (mmol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  57. Safety and Tolerability: blood chemistry - sodium concentration

    Sodium concentration (mmol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

  58. Safety and Tolerability: blood chemistry - chloride concentration

    Chloride concentration (mmol/L)

    Measured: Screening, Day 1 and 2 (single dosing), Day 1 to 4, 11 (multiple dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start13 Jan 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859333
Sponsor's protocol ID
IFR-01-01-2024
Status last verified
Jul 2025
First submitted
20 Feb 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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, 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 and 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 in people with Influenza and Viral Respiratory Infection, run by Valenta Pharm JSC at 1 site in Russia.

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 40 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics - Cmax (time frame: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06859333.

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 8 Jul 2025.

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