Rabies
Conditions
Interventions
Group 1:NM57S/NC08
Group 2:HRIG
Group 3:NM57S/NC08+V
Group 4:HRIG+V
Group 5:V
Group 6:Placebo
Sponsors
The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have fully understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial before the trial, and who voluntarily participate in the clinical trial, can communicate well with researchers, comply with the requirements of the whole study, and sign the written informed consent; 2. Men or women aged 18 to 50 years at the time of screening; 3. The body weight of female volunteers 45.0 to 80.0 kg, male volunteers 50.0 to 80.0kg, body mass index (BMI) between 18.0 and 26.0kg/m2 (including boundary value); 4. From 14 days before self-sufficiency to 6 months after the end of the trial, female volunteers had no fertility or egg donation plan and voluntarily took effective physical contraceptive measures, while male volunteers had no fertility or sperm donation plan from the first time to 6 months after the end of the trial and voluntarily took effective physical contraceptive measures; 5. According to the results of physical examination, vital signs, electrocardiogram, clinical laboratory examination and other auxiliary examinations during the screening period, combined with the previous medical history, the researcher judged that all the examination results were normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to the study drug (including excipients and similar drugs), or who suffer from serious allergic diseases or belong to allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of volunteers (inquiry) according to the judgment of researchers; 2. Patients who have a clear history of allergy to necessary substances (such as skin disinfectant) that may be contacted during the test (inquiry); 3. Patients who have a history of serious clinical diseases and are not cured within 6 months (180 days) before the first administration, or who are suffering from acute and chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry); 4. Patients with a history of autoimmune disease, rabies virus infection or chronic hepatitis (inquiry); 5. Patients with previous history of convulsion, epilepsy, mental or nervous system, or family history of convulsion and epilepsy (inquiry); 6. Patients who received major surgery within 3 months (90 days) before the first administration, or who received surgery that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry, inquiry); 7. Patients who have received rabies vaccination before (inquiry); 8. Patients with positive serum antibody in screening period (examination); 9. Within 3 months (90 days) before the first administration, patients who have received other vaccines (inquiries) than rabies vaccine, or who have used passive immunosuppressive agents or corticosteroids (inquiries, inquiries); 10. Patients who have used or are using drugs within 14 days before the first administration that may have a significant impact on the in vivo process or safety evaluation of the drug in this study (inquiry, inquiry); 11. Patients who participated in the clinical trial and used any clinical trial drug within 3 months (90 days) before the first administration, or planned to participate in other clinical trials during the study period (inquiry, inquiry); 12. Patients who often drink alcohol within 3 months (90 days) before the first administration (more than 3 times a week, and the average drinking time is equal to 50 degree white spirit >=200ml), or those who can't prohibit alcohol during the trial (inquiry); 13. Patients with positive alcohol breath test or test value > 0 mg / 100 ml (examination); 14. Patients who are addicted to smoking within 1 month (30 days) before the first administration (more than 10 cigarettes per day or equivalent amount of tobacco), or who are unable to prohibit smoking during the trial (inquiry); 15. Patients with blood loss / donation of more than 300 ml within 3 months (90 days) before the first administration (except for female physiological blood loss), or those receiving blood transfusion or using blood products, or those planning to donate blood within 1 month (30 days) after the end of the trial (inquiry); 16. Patients who drink too much coffee, strong tea, coke, chocolate and other caffeinated drinks or food (drinks: more than 8 cups per day, 200ml per cup on average) 14 days before the first administration (inquiry); 17. Within 24 hours before the first administration, patients who ingest alcoholic products or coffee, strong tea, cola, chocolate and other caffeinated drinks or food (inquiry); 18. Patients who can not avoid strenuous exercise from the first administration to the end of the trial (in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance and safety;PK;PD;ADA; | — |
Countries
China
Contacts
Public ContactJianchang He
The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine
Outcome results
None listed