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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
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• 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.
Locations
Other Locations
Russian Federation
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.
RECRUITING
Moscow
Time Frame
Start Date:2025-01-13
Estimated Completion Date:2025-12-31
Participants
Target number of participants:36
Treatments
Experimental: Single and multiple doses, 90 mg + 5 mg
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.
Experimental: Single and multiple doses, 90 mg + 10 mg
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.
Experimental: Single and multiple doses, 90 mg + 20 mg
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.