Prevention after exposure to suspected rabies virus
Conditions
Interventions
GR1801 injection alone group:GR1801 Injection
rabies vaccine alone group:rabies vaccine
GR1801 injection combined rabies vaccine group:GR1801 injection+rabies vaccine
Human rabies immunoglobulin combined rabies vaccine group:HRIG+rabies vaccine
Sponsors
Huashan Hospital affiliated to Fudan University, The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 to 45 years old (including the boundary value) at the time of screening; 2. The weight of male volunteers is greater than or equal to 50.0kg, and the weight of female volunteers is greater than or equal to 45.0kg; 3. Voluntarily participate in this clinical trial and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug (including excipients and similar drugs); 2. History of autoimmune disease in the past; 3. There is a history of active infection or disease; 4. Have a history of active tuberculosis or active tuberculosis infection at the time of screening; 5. There is a history of malignant tumor; 6. Before the first administration, the investigator judges that there is a history of serious clinical disease and has not been cured; 7. Have plans to participate in other clinical trials during this trial; 8. There is a history of substance abuse (inquiry) or a positive substance abuse screening (examination) at the time of screening; 9. The results of laboratory tests or other auxiliary tests at the time of screening are judged by the investigator to be abnormal and have clinical significance; 10. Women with a positive pregnancy test at screening (exam); 11. Other reasons that the investigator considers inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (any spontaneously reported and all observed adverse events, serious adverse events); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rabies virus neutralizing antibody levels;Pharmacokinetic evaluation index;immunogenicity; | — |
Countries
China
Contacts
Public ContactZhang Jing; He Jianchang
Huashan Hospital affiliated to Fudan University
Outcome results
None listed