Actively Recruiting

Phase 1
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06859333

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

Led by Valenta Pharm JSC · Updated on 2025-07-08

36

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before study activities
  • Male or female aged 18 to 45 years of Caucasian race
  • Verified healthy status with no abnormalities by clinical, laboratory, and instrumental exams
  • Blood pressure: systolic 100-130 mm Hg, diastolic 70-85 mm Hg
  • Heart rate between 60 and 89 beats per minute
  • Respiratory rate between 12 and 20 breaths per minute
  • Body temperature from 36.0°C to 36.9°C
  • Body mass index between 18.5 and 30 kg/m² with minimum weight ≥55 kg for men and ≥45 kg for women
  • Agreement to use effective contraception during the study and for 30 days after; negative urine pregnancy test for women of childbearing potential
Not Eligible

You will not qualify if you...

  • Known allergic history or hypersensitivity to study drug components or excipients
  • Drug intolerance to study drug components or excipients
  • Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption
  • Chronic diseases of kidneys, liver, gastrointestinal tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, immune systems, skin, blood, or vision organs
  • History of gastrointestinal surgery except appendectomy at least 1 year prior
  • Conditions affecting drug absorption, distribution, metabolism, or excretion
  • Acute infectious diseases within 4 weeks before screening
  • Use of drugs affecting hemodynamics, liver function, or prolonging QT interval within 2 months before screening
  • Regular drug use within 2 weeks, or single use within 7 days before screening
  • Blood or plasma donation within 3 months before screening
  • Use of hormonal contraceptives within 2 months before screening
  • Use of depot drug injections within 3 months before screening
  • Pregnancy, lactation, or positive pregnancy test
  • Unprotected sexual intercourse within 30 days before dosing for women of childbearing potential
  • Participation in another clinical trial within 3 months before or concurrent with this study
  • Alcohol consumption over 10 units per week in last month or history of substance abuse
  • Smoking more than 10 cigarettes per day currently or in past 6 months
  • Consumption of alcohol, caffeine, xanthine products, certain fruits, or St. John's wort within 7 days before dosing
  • Dehydration within 24 hours before dosing
  • Positive tests for HIV, syphilis, hepatitis B or C
  • Abnormal electrocardiogram including prolonged QTc interval
  • Risk factors for torsades de pointes
  • Positive urine drug or alcohol tests at screening
  • Planning hospitalization unrelated to protocol during study
  • Inability or unwillingness to comply with protocol requirements
  • Belonging to vulnerable volunteer groups
  • Other conditions that may interfere with participation or lead to early withdrawal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

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

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

3

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