Rabies
Conditions
Interventions
Experimental IIa 1 group:rhRIG (20IU/kg)
Experimental IIa 2 group:rhRIG (40IU/kg)
Control IIa group:HRIG (20IU/kg)
Experimental IIb 1 group:rhRIG (20IU/kg)+vaccine
Experimental IIb 2 group:rhRIG (40IU/kg)+vaccine
Control IIb 1 group:HRIG (20IU/kg)+vaccine
Control IIb 2 group:placebo+vaccine
Sponsors
Chaoyang District of Beijing Center For Diseases Control and prevention
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 55 years; 2. According to the medical history, physical examination, and the clinical judgment of the investigator at the time of enrollment, the subject should have no significant health problems, or the condition is stable, or the medication is stable; 3. Subjects and their spouses need adequate contraception from the screening date until the 90th day; 4. Male subjects must agree not to donate sperm from the first enrollment until the 90th day; 5. The subject signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of previous rabies exposure or immunization (rabies vaccine and/or immunoglobulin); 2. Within 2 weeks prior to the first dose, the subject has clinically significant acute illness or infection, including fever (>37.0 degree C), according to the investigator's clinical judgment; 3. After a medical history or physical examination, a history of heart, liver, kidney, blood, digestive tract, nervous system, mental disorders and metabolic abnormalities are found; 4. Pregnancy or planned pregnancy during the study period, or breastfeeding; 5. According to the investigator's judgment, the subject has a clinically significant immunodeficiency or autoimmune disease history and/or family history; 6. According to the investigator's judgment, a clinically significant allergic reaction or hypersensitivity reaction is known or suspected; 7. Vaccination has been scheduled for the next 3 months after the first dose; 8. Take immunosuppressive agents or other immunomodulatory drugs for more than 14 days within 6 months prior to the first administration of the test drug; 9. Use hormonal drugs within 3 days prior to the first dose; 10. Donate blood or massive blood loss within 56 days before the first dose; 11. Donate plasma within 7 days prior to the first dose; 12. Blood transfusion or blood products within 6 months prior to the first dose; 13. Suspected of non-compliance with research operations; 14. Drink alcohol within 12 hours before the first dose; 15. Cigarette smoking is >20 cigarettes per day; 16. Subjects have a clear history of allergies to antibiotics; 17. Any other circumstances that the investigator believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neutralizing antibody activity; | — |
Countries
China
Contacts
Public ContactShi Nianmin
Beijing Chaoyang Center for Disease Control and Prevention
Outcome results
None listed