Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Fo… (NCT06859333) | Clinical Trial Compass
RecruitingPhase 1
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
Russia36 participantsStarted 2025-01-13
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.).
What they're measuring
1
Pharmacokinetics - Cmax
Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
2
Pharmacokinetics - tmax
Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
3
Pharmacokinetics - AUC0-t
Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
4
Pharmacokinetics - AUC0-inf
Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose
5
Pharmacokinetics - AUCextr
Timeframe: From 0 hours extrapolated to infinity after single dose and from 48 hours extrapolated to infinity after multiple dose
6
Pharmacokinetics - t1/2
Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)
7
Pharmacokinetics - kel
Timeframe: From 0 to 24 hours (single dose); from 48 to 72 hours (multiple dose)