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RECRUITINGPHASE1

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

NCT06859333•Valenta Pharm JSC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
•1. Known allergic history.
+29 more criteria

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.).
•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.
+1 more criteria

Locations (1)

State Budgetary Healthcare Institution of the City of Moscow "City Clinical Hospital No. 15 named after O.M. Filatov of the Department of Health of Moscow."

Moscow, Russia

Key Dates

Start Date

January 13, 2025

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

July 8, 2025

Enrollment

ESTIMATED participants

Conditions

InfluenzaViral Respiratory Infection

Interventions

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

DRUG

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

NCT07291635

Influenza

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A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

NCT06094010

Influenza

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RECRUITINGNA

Dime La VerDAD: Verify, Debunk, and Disseminate

NCT06417762

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility