Study to Evaluate the Efficacy, Safety, and Tolerability of the Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.

A Multicenter, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of the Investigational Product Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.

The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).

Study Overview

• Status: Recruiting
• Conditions: Influenza; Acute Respiratory Viral Infection
• Intervention / Treatment: Drug: Ingavirin Forte, 90 mg + 5 mg, Capsules; Drug: Ingavirin Forte, 90 mg + 10 mg, Capsules; Drug: Ingavirin Forte, 90 mg + 20 mg, Capsules; Drug: Ingavirin, 90 mg, Capsules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russia
  • Ivanovo, Russia, 153025
    • Recruiting
    • Regional Budgetary Healthcare Institution "Kuvaev Ivanovo Clinical Hospital"
    • Contact: Svetlana Ushakova, MD, PhD; Phone Number: +7 (910) 992-39-62; Email: svetland1962@mail.ru
  • Kirov, Russia, 610027
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
    • Contact: Tatiana Chudinovskikh, MD, PhD; Phone Number: +7 (8332) 62-77-28; Email: Tatiana.сhudinovskikh@gmail.com
  • Kirov, Russia, 610046
    • Recruiting
    • "Medical and Diagnostic Center Veris" LLC
    • Contact: Nadezhda Trushnikova; Phone Number: + 7 (8332) 62-75-68; Email: uddefola@mail.ru
  • Moscow, Russia, 117042
    • Recruiting
    • State Budgetary Healthcare Institution of the City of Moscow "Consultative and Diagnostic Polyclinic № 121 of the Moscow City Department of Healthcare"
    • Contact: Dmitry Bystritsky; Phone Number: +7 (916) 777-24-11; Email: bystritskiida@mail.ru
  • Moscow, Russia, 119571
    • Recruiting
    • Unimed-C Jsc
    • Contact: Elena Volnaya; Phone Number: +7 (495)-135-50-10; Email: drvolnaya@yandex.ru
  • Perm, Russia, 614070
    • Recruiting
    • "Professor's Clinic" LLC
    • Contact: Svetlana Teplykh, MD, PhD; Phone Number: +7 (919) 498-29-31; Email: profkliniki@mail.ru
  • Saint Petersburg, Russia, 194156
    • Recruiting
    • "Aurora MedFort" LLC
    • Contact: Igor Balaban; Phone Number: +7 (921) 903-94-95; Email: igorbalaban.81@mail.ru
  • Saint Petersburg, Russia, 195197
    • Recruiting
    • "Eosmed" LLC
    • Contact: Ekaterina Polyakova, MD,PhD; Phone Number: +7 (812) 988-00-46; Email: polyakova_ea@yahoo.com
  • Saint Petersburg, Russia, 199178
    • Recruiting
    • "OrCli Hospital" LLC
    • Contact: Varvara Popova, MD,PhD; Phone Number: +7 (921) 753-63-81; Email: varvara-pa@mail.ru
  • Saransk, Russia, 430005
    • Recruiting
    • Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Mordovia State University"
    • Contact: Natalya Selezneva, MD, PhD; Phone Number: + 7 (8342) 33-34-09; Email: nata_rm@mail.ru
  • Saratov, Russia, 410019
    • Recruiting
    • "DNA Research Center" LLC
    • Contact: Inna Gamova, MD, PhD; Phone Number: +7 (845) 249-43-14; Email: innapris@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
2. Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;
3. Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);

4. Presence of clinically significant signs of influenza or acute respiratory viral infections at screening:

   • Body temperature >38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;
   • Presence of at least two of the following symptoms of influenza or other acute respiratory viral infections (cough, rhinorrhea, sore throat, or a throat irritation) each rated non less than 6 points on a numeric rating scale (NRS);
   • Presence of at least one of the following systemic manifestations of influenza or other acute respiratory viral infections (headache, myalgia, or general weakness) rated non less than 6 points on a numeric rating scale (NRS).
5. Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours;
6. No clinical indications for hospitalization at the time of study enrollment;

7. Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion. The follwing subjects are eligible for inclusion in the study:

   • Females of childbearing potential must have a negative pregnancy test and use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives, contraceptive subdermal implant, intrauterine hormonal system, intrauterine device. Females not of childbearing potential (i.e., with a history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, comfirmed infertility, or ≥ 2 of menopause) are also eligible for participation;
   • Males with reptoductive potential must use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives. Males with infertility or a history of vasectomy are also eligible for participation;

Exclusion Criteria:

1. Clinically significant allergic history;
2. Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
3. Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
5. Clinical suspicion of pneumonia of any etiology, or other bacterial infection (e.g. sinusitis, otitis media, urinary tract infection, meningitis, sepsis) requiring initiation for antibacterial therapy;
6. Nasal obstruction due to structural pathology, such as sequelae of nasal trauma, nasal polyps, septal deviation, or other organic causes;
7. History of vasomotor rhinitis;
8. Administration of antibiotics, antiviral (including Ingavirin), or immunomodulatory agents within 48 hours prior to study, and/or anticipated need for any of these agents during the study;
9. Vaccination within 90 days prior to study enrollment;
10. Uncontrolled diabetes mellitus;
11. Obesity, class II or III (body mass index ≥35 kg/m²);
12. Pregnancy or lactation;
13. Positive test for SARS-CoV-2 at screening;
14. History of autoimmune diseases;
15. Current or past HIV, syphilis, hepatitis B and/or C, or tuberculosis;
16. Known or suspected history of alcohol, psychotropic drug, or substance abuse or dependence;
17. History of chronic respiratory disease, including but not limited to: chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, diffuse panbronchiolitis, pulmonary emphysema, or pulmonary fibrosis;
18. Chronic heart failure, New York Heart Association (NYHA) functional class III or IV;
19. Current or past psychiatric disoder;
20. Any clinically significant cardiovascular, renal, hepatic, gastrointestinal , endocrine, or neurological disoder, including severe uncompensated chronic conditions (e.g., chronic kidney disease, chronic liver disease) or acute illness, or any other medical or psychiatric condition that, in investigator's opinion, could pose a safety risk to the subject if they participate in the study;
21. Subject's refusal to use an adequate method of contraception or to practice continuous sexual abstinence throughout the study and for 30 days after study completion;
22. Participation in another clinical trial within 3 months prior to screening;
23. Other conditions which, in the judgment of the investigator, could compromise the subject's participation in the study or pose an undue risk.

Exclusion Criteria:

1. Subject's decision to withdraw from the study (withdrawal of informed consent);
2. Investigator's decision to discontinue the subject from the study in the subject's best interest;
3. Investigator-determined need for a concomitant therapy explicitly prohibited by the protocol of clinical study;
4. Subject's use of a therapy prohibited by the protocol;
5. Positive urine test for beta-human chorionic gonadotropin (β-hCG) in females of childbearing potential;
6. Lack of adequate cooperation by the subject with the investigator during the study;
7. Emergence during the study of conditions or events that jeopardize subject safety (e.g., hypersensitivity reactions, serious adverse events [SAEs]) or, in the investigator's medical judgment, worsen the subject's prognosis or preclude further participation in the clinical study;
8. Incorrect inclusion of a subject who does not meet the protocol-specified inclusion and/or exclusion criteria;

9. Major deviation from the treatment regimen, defined as:

   • Missing two or more consecutive doses of the investigational medicinal product (IMP) or comparator;
   • Total intake of fewer than 80% or more than 120% of the planned total number of capsules (full course includes 10 capsules);
10. Confirmed diagnosis of COVID-19;
11. Occurrence during the study of any other condition that precludes adherence to the protocol;
12. Subject's death.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ingavirin Forte, 90 mg + 5 mg, Capsules; Subjects will receive Ingavirin Forte, 90 mg + 5 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.	Drug: Ingavirin Forte, 90 mg + 5 mg, Capsules; 90 mg + 5 mg, 1 capsule twice a day, for 5 days; Other Names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
Experimental: Ingavirin Forte, 90 mg + 10 mg, Capsules; Subjects will receive Ingavirin Forte, 90 mg + 10 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.	Drug: Ingavirin Forte, 90 mg + 10 mg, Capsules; 90 mg + 10 mg, 1 capsule twice a day, for 5 days; Other Names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
Experimental: Ingavirin Forte, 90 mg + 20 mg, Capsules; Subjects will receive Ingavirin Forte, 90 mg + 20 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.	Drug: Ingavirin Forte, 90 mg + 20 mg, Capsules; 90 mg + 20 mg,1 capsule twice a day, for 5 days; Other Names: Imidazolyl ethanamide pentandioic acid + N,N'-bis-[2-(1,3-Diazocyclopenta2,4-dien-4-yl)ethyl] diamide of malonic acid
Active Comparator: Ingavirin Forte, 90 mg , Capsules; Subjects will receive Ingavirin, 90 mg, 1 capsule twice daily (morning and evening), for 5 consecutive days.	Drug: Ingavirin, 90 mg, Capsules; 90 mg, 1 capsule twice a day, for 5 days; Other Names: Imidazolyl ethanamide pentandioic acid
Placebo Comparator: Placebo, Capsules; Subjects will receive Placebo, 1 capsule twice daily (morning and evening), for 5 consecutive days.	Drug: Placebo; 1 capsule twice a day, for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (in hours) from the first dose of the study drug to the sustained resolution of all the following symptoms/events (with each resolved symptom/event persisting for at least 24 hours without the use of NSAIDs and/or decongestants):	fever (the first time point at which body temperature remains stably normalized (<37.0°C) for 24 h);; runny nose/rhinorrhoea (the first time point with Numeric Rating Scale (NRS) ≤ 2 which maintained for ≥24 h);; nasal congestion/stuffiness (the first time point with NRS ≤ 2 which maintained for ≥24 h);; sore throat (the first time point with NRS ≤ 2 which maintained for ≥24 h);; throat irritation (the first time point with NRS ≤ 2 which maintained for ≥24 h);; cough (the first time point with NRS ≤ 2 which maintained for ≥24 h);; generalized weakness/malaise (the first time point with NRS ≤ 2 which maintained for ≥24 h);; headache (the first time point with NRS ≤ 2 which maintained for ≥24 h);; myalgia (the first time point with NRS ≤ 2 which maintained for ≥24 h).	Day 1 - Day 10 of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily symptom severity score based on the NRS (arithmetic mean of the scores over a 24-hour period). A "day" will be calculated as 24-hour intervals starting from the time of the first dose administration.	fever (arithmetic mean of the daily scores);; runny nose/rhinorrhoea (arithmetic mean of the daily scores);; nasal congestion/stuffiness (arithmetic mean of the daily scores);; sore throat (arithmetic mean of the daily scores);; throat irritation (arithmetic mean of the daily scores);; cough (arithmetic mean of the daily scores);; generalized weakness/malaise (arithmetic mean of the daily scores);; headache (arithmetic mean of the daily scores);; myalgia (arithmetic mean of the daily scores).	Day 1 - Day 10 of the study.
Time (in hours) from first dose of study drug to resolution of disease symptoms.	fever (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; runny nose/rhinorrhoea (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; nasal congestion/stuffiness (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; sore throat (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; throat irritation (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; cough (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; generalized weakness/malaise (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; headache (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h);; myalgia (the first time point at which symptom severity remains ≤ 2 on NRS for 24 h).	Day 1 - Day 10 of the study.
Proportion of subjects using intranasal decongestant spray for nasal obstruction relief at Visit 2 (Day 3) and Visit 3 (Day 6).	Rate of nasal decongestant spray use for symptomatic relief of nasal obstruction.	Day 3, Day 6 of the study.
Mean daily frequency of decongestant nasal spray use at Visit 2 (Day 3) and Visit 3 (Day 6).	The mean daily frequency of decongestant use will be calculated for each subject as the total number of administrations from the first dose of the investigational product up to the target visit, divided by the number of days in that period.	Day 3, Day 6 of the study.
Proportion of subjects using analgesic and/or NSAID medications at Visit 2 (Day 3) and Visit 3 (Day 6).	Rate of using analgesic and/or NSAID medications to relif symptoms of Influenza or ARVI.	Day 3, Day 6
Mean daily frequency of analgesic and/or NSAID use at Visit 2 (Day 3) and Visit 3 (Day 6).	The mean daily frequency of analgesic and/or NSAID use will be calculated for each subject as the total number of administrations from the first dose of the investigational product up to the target visit, divided by the number of days in that period.	Day 3, Day 6 of the study.
Proportion of subjects with viral elimination by Visit 3 (Day 6).	Proportion of subjects with a negative PCR test result	Day 6 of the study.
Assessment of clinical sign severity via pharyngoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).	Assessment of the severity of hyperemia and ridge-like thickening of the edges of the palatine arches;; Assessment of the severity of caseous-purulent plugs or liquid pus in the tonsillar lacunae;; Assessment of the severity of edema of the tonsils;; Assessment of the severity of edema of the palatine arches;; Assessment of the severity of edema of the uvula;; Assessment of the severity of edema of the posterior pharyngeal wall. Each symptom will be assessed on a 4-point severity scale, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom.	Day 3, Day 6 of the study.
Assessment of clinical sign severity via rhinoscopy at Visit 2 (Day 3) and Visit 3 (Day 6).	Assessment of the severity of nasal discharge; Assessment of the severity of nasal mucosal hyperemia; Assessment of the severity of nasal mucosal edema Each symptom will be assessed on a 4-point severity scale, where: 0 points - no symptom; 1 point - the minimum severity of the symptom; 2 points - moderate severity of the symptom; 3 points - the maximum severity of the symptom.	Day 3, Day 6 of the study.
Assessment of treatment effectiveness by the Investigator on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).	A 5-point scale will be used to assess treatment effectiveness, where: 1 point - absence of clinical symptoms, 2 points - regression of the main clinical symptoms, 3 points - reduction in the severity of clinical symptoms, 4 points - lack of positive dynamics of clinical symptoms, 5 points - worsening of clinical symptoms.	Day 3, Day 6 of the study.
Subject's assessment of treatment effectiveness on a 5-point scale at Visit 2 (Day 3) and Visit 3 (Day 6).	To assess treatment effectiveness from the subject's perspective, a 5-point scale will be used, where: 1 point - poor, 2 points - satisfactory, 3 points - good, 4 points - very good, 5 points - excellent.	Day 3, Day 6 of the study.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability: adverse events rate	Number and frequency of adverse events and serious adverse events.	Screening (Day-1), and from Day 1 to Day 10
Safety and Tolerability: adverse events associated with the study drug	Number and frequency of adverse events associated with the study drug.	From Day 1 to Day 10
Safety and Tolerability: serious adverse events associated with the study drug	Number and frequency of serious adverse events associated with the study drug.	From Day 1 to Day 10
Safety and Tolerability: proportion of subjects with at least one adverse event.	Proportion of subjects with one or more adverse events.	Screening (Day-1), and from Day 1 to Day 10
Safety and Tolerability: treatment discontinuation	roportion of subjects who discontinued treatment due to an adverse events.	From Day 1 to Day 10
Safety and Tolerability: vital signs - systolic blood pressure (SBP)	SBP, mmHg	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: vital signs - diastolic blood pressure (DBP)	DBP, mmHg	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: vital signs - respiratory rate (RR)	RR, breaths per minute	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: vital signs - body temperature	Body temperature, Celsius temperature scale	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Subject complaints	Description of complaints, recieved from subject	Screening (Day-1), and from Day 1 to Day 10
Physical examination results - cardiovascular system	An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - respiratory system	An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - digestive tract	An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - endocrine system	An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - musculoskeletal system	An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - nervous system	An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - skin/visible mucous membranes	An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - genitourinary system	An assessment of the condition of the genitourinary system on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - otorhinolaryngological organs	An assessment of the condition of the otorhinolaryngological organs on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Physical examination results - organ of vision	An assessment of the condition of the organ of vision on physical examination (normal condition or list of abnormal conditions, if any)	Screening, Day 1, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate	12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval	12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex	12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)	12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: complete blood count - hemoglobin	Hemoglobin, g/dL	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: complete blood count - hematocrit	Hematocrit, %	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: complete blood count - red blood cells	Red blood cell count (cells/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - leukocyte count	Leukocyte count (cells/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - platelet count	Platelet count (cells/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - erythrocyte sedimentation rate	Erythrocyte sedimentation rate (mm/h)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - band neutrophils	Leukocyte formula (band neutrophils, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - segmented neutrophils	Leukocyte formula (segmented neutrophils, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - eosinophils	Leukocyte formula (eosinophils, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - basophils	Leukocyte formula (basophils, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - monocytes	Leukocyte formula (monocytes, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: clinical blood test - lymphocyte	eukocyte formula (lymphocytes, %)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - alanine transaminase	Alanine transaminase activity (U/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - aspartate transaminase	Aspartate transaminase activity (U/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - bilirubin	Total bilirubin concentration (micromol/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - glucose	Glucose concentration (mmol/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - total protein	Total protein in blood serum (g/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - creatinine	Creatinine concentration (micromol/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: blood chemistry - urea	Urea in blood serum (mmol/L)	Screening, Day 3, Day 6, and Day 10 of the study.
C-reactive protein (CRP)	Serum C-reactive protein (mg/L))	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - pH	pH of the urine	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - specific gravity	Specific gravity of the urine	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - protein	Protein concentration (g/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - glucose	Glucose concentration (mmol/L)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - red blood cells	Red blood cell content (number in sight)	Screening, Day 3, Day 6, and Day 10 of the study.
Safety and Tolerability: urinalysis - white blood cells	White blood cell content (number in sight)	Screening, Day 3, Day 6, and Day 10 of the study.

Collaborators and Investigators

• Sponsor: Valenta Pharm JSC

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; pentanedioic acid imidazolyl ethanamide
• Other Study ID Numbers: IFR-02-03-2025

Drug and device information, study documents

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