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 | Recruiting Phase 1

• 1 other identifier: IFR-01-01-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza; Viral Respiratory Infection

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (58)

• Adverse event type

  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

  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

  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

  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

  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)

Study Arms (3)

Single and multiple doses, 90 mg + 5 mg

EXPERIMENTAL

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

Single and multiple doses, 90 mg + 10 mg

EXPERIMENTAL

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

Single and multiple doses, 90 mg + 20 mg

EXPERIMENTAL

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

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

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

Single and multiple doses, 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 DRUG

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

Single and multiple doses, 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 DRUG

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

Single and multiple doses, 90 mg + 20 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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).

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.).
• 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.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 5, 2025
• Study Start: January 13, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)