Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingav
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.
| Condition(s) | Influenza, Viral Respiratory Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 | 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 w |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Valenta Pharm JSC |
| Locations | Moscow, Russia |
| Start date | 2025-01-13 |
| NCT ID | NCT06859333 |
| Official listing | https://clinicaltrials.gov/study/NCT06859333 |