Rabies
Conditions
Interventions
Group 1:Of the 16 cases, 12 were randomly assigned to the 10 IU/KG group and 4 were assigned to the placebo group. On day 0, an intramuscular injection was administered in the lateral thigh.
Group 2:Of the 28 cases, 12 were randomly assigned to the 20 IU/KG group, 12 were assigned to the HRIG group, and 4 were assigned to the placebo group. On day 0, an intramuscular injection was adminis
Group 3:Of the 16 cases, 12 were randomly assigned to the 40 IU/KG group, and 4 were assigned to the placebo group. On day 0, an intramuscular injection was administered in the lateral thigh.
Group 4:Of the 16 cases, 12 were randomly assigned to the 80 IU/KG group, and 4 were assigned to the placebo group. On day 0, an intramuscular injection was administered in the lateral thigh.
Group 5:Of the 16 cases, 12 were randomly assigned to the 10 IU/KG monoclonal antibody + vaccine group, and 4 were assigned to the placebo + vaccine group. On day 0, an intramuscular injection was adm
Group 6:Of the 28 cases, 12 were randomly assigned to the 20 IU/KG monoclonal antibody + vaccine group, 12 were assigned to the HRIG + vaccine group, and 4 were assigned to the placebo + vaccine group
Group 7:Of the 16 cases, 12 were randomly assigned to the 40 IU/KG monoclonal antibody + vaccine group, and 4 were assigned to the placebo + vaccine group. On day 0, an intramuscular injection was adm
Sponsors
Wuhan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy persons aged 18-60 years old (including the critical value), gender is not limited, and legal identity certificates can be provided; 2. The subject voluntarily agrees to participate in the study and signs the informed consent form; 3. Female subjects have no fertility or egg donation plan and voluntarily take effective physical contraceptive measures within 14 days before dosing to 6 months after dosing, and male subjects have no fertility or sperm donation plan within 6 months after drug use and voluntarily take effective physical contraceptive measures; 4. Female subjects weigh >=45.0 kg and =50.0 kg and <=80.0 kg, and body mass index (BMI) is between 18.0~26.0 kg/m^2 (including the boundary value) (BMI=weight kg/height m^2); 5. Vital signs examination [reference value range of vital signs: systolic blood pressure 90~140 mmHg, diastolic blood pressure 60~90 mmHg, pulse 50~100 beats/min (including boundary values), body temperature assessed by the investigator according to the standards of the research center], physical examination, clinical laboratory tests during the screening period, and other auxiliary examination results are normal or abnormal as judged by the investigator to be clinically significant.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the study drug (including excipients and similar drugs), or suffer from severe allergic diseases or belong to allergic constitution (such as allergies to two or more drugs, food or pollen), which may be impaired by the investigator's judgment; 2. Those who have a clear history of allergy to essential substances (such as skin disinfectants) that may be exposed during the test; 3. Those who have a history of clinical serious illness and have not been cured within 6 months (180 days) before screening, or those who are currently suffering from acute and chronic diseases that may significantly affect the metabolism or safety evaluation of the study drug; 4. Those who have a history of autoimmune diseases or chronic hepatitis; 5. Those who have a history of convulsions, epilepsy, psychiatric or nervous system in the past, or a family history of convulsions and epilepsy; 6. Those who have undergone major surgery within 3 months (90 days) before screening, or have undergone surgery that may significantly affect the metabolism or safety evaluation of the study drug; 7. Those who have been vaccinated against rabies for human use in the past, or who are suspected of having a history of rabies exposure (rabies exposure refers to being bitten, scratched, licked on mucous membranes or broken skin by rabies, suspected rabies or host animals that cannot be determined whether they have rabies, or open wounds or mucous membranes in direct contact with saliva or tissues that may contain rabies virus), can be inquired; 8. Have received vaccines other than rabies vaccine within 1 month (30 days) before screening; 9. Those who have used other antibody drugs or immunoglobulins within 3 months (90 days) before screening; 10. Those who have used passive immune preparations, immunosuppressants or corticosteroids within 3 months (90 days) before screening; 11. Those who have used or are using drugs that affect the metabolism or safety evaluation of this study within 14 days before screening; 12. Those who have participated in clinical trials and used any clinical trial drugs or devices within 3 months (90 days) before screening, or plan to participate in other clinical trials during this study; 13. Regular alcohol consumption within 3 months (90 days) before screening, that is, an average of more than 2 units of alcohol per day (1 unit = 17.7 mL ethanol, that is, 1 unit = 357 mL of beer with 5% alcohol or 43 mL of liquor with 40% alcohol or 147 mL of wine with 12% alcohol), or who cannot abstain from alcohol during the trial; 14. Those who have been addicted to smoking (more than 5 cigarettes or equivalent tobacco per day) within 3 months (90 days) before screening, or who cannot quit smoking during the trial; 15. Loss/donation of more than 300 mL of blood (except for physiological blood loss in females) within 3 months (90 days) before screening, or those who have received blood transfusions or used blood products, or who plan to donate blood during the trial or within 1 month (30 days) after the end of the trial; 16. Those who cannot avoid strenuous exercise within 14 days after administration; 17. Those with a history of drug abuse; 18. Those with one of the following laboratory abnormalities: alanine aminotransferase >1.5× upper limit of normal (ULN), serum creatinine > 1.0×ULN; Routine blood count: neutrophil count < 1.5×10^9/L, platelet count < 100×10^9/L, hemoglobin < 100 g/L; 19. Pregnant/lactating females; 20. Tho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Pharmacokinetic (PK) ;Pharmacodynamic (PD) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Anti-Drug Antibody ; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Infectious Disease Hospital
Outcome results
None listed