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

Recruiting now · Phase 1

Conditions studied: Influenza, Viral Respiratory Infection

In brief

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.

Key facts

Study ID

NCT06859333

Run by

Valenta Pharm JSC

People needed

36

Starts

2025-01-13

Expected to finish

2025-12-31

Last updated by the study team

2025-07-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• 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, Russia (enrolling)

Full record on ClinicalTrials.gov

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