Healthy adults Infections and Infestations
Conditions
Interventions
The first injection of Fortepren® was performed 2 days after the screening. On the 9th day, volunteers were hospitalized for 5 days. Fortepren® at a dose of 5 mL (20 mg) was administered intramuscular
Sponsors
GamaVetFarm Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 45 years old 2. Smoke less than 10 cigarettes per day 3. Verified diagnosis of "practically healthy" according to standard clinical, laboratory and instrumental methods of examination 4. Negative tests for HIV, syphilis (RW), HBs-antigen and hepatitis C (HCV RNA), a negative pregnancy test (for female volunteers) 5. Body mass index of volunteers did not go beyond ± 15% overall weight and growth index. 6. Participants in the study complied with an adequate method of contraception during the entire time from the date of signing the informed consent form prior to the completion of participation in the study
Exclusion criteria
Exclusion criteria: 1. Liver or kidney disease; any other disease, which, in the opinion of the investigator, may affect the results of the study or may lead to poor health during the study 2. Clinically significant abnormalities in laboratory results 3. Course medication (including herbal products and dietary supplements) for prophylactic or therapeutic purposes in the past month 4. The presence of antibodies to HIV, hepatitis B and C 5. Consuming alcohol or narcotic drugs for 4 days prior to the study 6. Donation of blood / plasma, surgery (in the hospital) for 12 weeks prior to the study 7. Participation in other clinical studies (or study drug) within 3 months prior to the study 8. Failure to understand or follow the instructions of the Protocol 9. Receive more than 10 units of alcohol per week (1 unit of alcohol equivalent to ½ liter of beer, 200 ml of wine or 50 ml of alcohol) or anamnestic information about alcoholism, abuse of drugs 10. Smoking more than 10 cigarettes a day 11. A positive test for the presence of alcohol in the breath 12. A positive urine test for drug abuse and narcotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events or changes in physical, vital, blood, and biomarker indices. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation the safety and tolerability of Fortepren® was carried using the following parameters: 1. Adverse events and serious adverse events (AEs and SAEs) 2. Deviations of laboratory tests (common clinical and biochemical blood analysis) | — |
Countries
Russian Federation
Outcome results
None listed