Rabies
Conditions
Interventions
Monotherapy Group 1:40 IU/kg monoclonal antibody, intramuscular injection on the outer thigh on day 0
Monotherapy Group 2:80 IU/kg monoclonal antibody group, intramuscular injection on the outer thigh on day 0
Monotherapy Group 3:20IU/kg HRIG, Day 0: Intramuscular injection of lateral thigh
Combination Therapy Group 1:40 IU/kg monoclonal antibody combined vaccine, injected intramuscularly into the lateral thigh on day 0
On days 0, 3, 7, 14, and 28, rabies vaccine should be injected into the deltoid muscle of the upper arm. On day 0, the vaccine should be injected as soon as possible after the administration of the ex
Combination Therapy Group 2:80 IU/kg monoclonal antibody combined vaccine, injected intramuscularly into the lateral thigh on day 0
Combination Therapy Group 3:20IU/kg HRIG combination vaccine, injected intramuscularly into the lateral thigh on day 0
Combination Therapy Group 4:Placebo combined vaccine, injected intramuscularly into the lateral thigh on day 0
Sponsors
Wuhan Infectious Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy individuals aged 18-60 years (inclusive), of any gender, who can provide valid legal identification. 2. Participants voluntarily agree to participate in the study and provide written informed consent. 3. Female participants must have no plans for pregnancy or egg donation from 14 days prior to dosing until 6 months after dosing and must voluntarily use effective physical contraception. Male participants must have no plans for fathering children or sperm donation for 6 months after dosing and must voluntarily use effective physical contraception. 4. Body weight must be >=45.0 kg and =50.0 kg and <=80.0 kg for male participants. Body Mass Index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight [kg] / height [m]²). 5. Vital signs examination (reference ranges: systolic blood pressure 90–140 mmHg, diastolic blood pressure 60–90 mmHg, pulse 50–100 beats per minute, all inclusive; body temperature assessed by the investigator according to the study site's standard), physical examination, clinical laboratory tests, and other auxiliary examinations during the screening period are either within normal ranges or assessed by the investigator as having abnormalities that are not clinically significant.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational product (including excipients or drugs of the same class), or individuals with a history of severe allergic disease or considered allergic constitution (e.g., allergy to two or more drugs, foods, or pollen) deemed by the investigator to potentially compromise participant safety. 2. History of definite allergy to substances necessarily encountered during the trial (e.g., skin disinfectants). 3. History of clinically significant illness within 6 months (180 days) prior to screening that remains unresolved, or presence of acute or chronic disease judged by the investigator to potentially significantly affect the metabolism or safety evaluation of the investigational product. 4. History of autoimmune disease or chronic hepatitis. 5. History of convulsions, epilepsy, psychiatric, or neurological disorders, or family history of convulsions or epilepsy. 6. Undergone major surgery within 3 months (90 days) prior to screening, or surgery deemed by the investigator to potentially significantly affect the metabolism or safety evaluation of the investigational product. 7. History of prior vaccination with human rabies vaccine or suspected history of rabies virus exposure (defined as bite, scratch, lick on mucosa or broken skin by a rabid, suspected rabid, or untestable rabid animal, or direct contact of open wounds/mucosa with potentially rabies virus-containing saliva or tissues, as determined by inquiry). 8. Positive screening test for anti-rabies virus antibodies during the screening period. 9. Vaccination with any vaccine other than rabies vaccine within 1 month (30 days) prior to screening. 10. Use of any antibody-based drugs or immunoglobulins within 3 months (90 days) prior to screening. 11. Use of passive immunizing agents, immunosuppressants, or corticosteroids within 3 months (90 days) prior to screening. 12. Use of medications known to affect the metabolism or safety evaluation of the investigational product within 14 days prior to screening or current use. 13. Participation in another clinical trial involving any investigational drug or device within 3 months (90 days) prior to screening, or planning to participate in other clinical trials during this study period. 14. Regular alcohol consumption averaging >2 units per day (1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% spirits, or 147 mL of 12% wine) within 3 months (90 days) prior to screening, or inability to abstain from alcohol during the trial. 15. Regular smoking (>5 cigarettes per day or equivalent tobacco use) within 3 months (90 days) prior to screening, or inability to abstain from smoking during the trial. 16. Blood loss or blood donation >300 mL (excluding physiological blood loss in females), or receipt of blood transfusion or blood products within 3 months (90 days) prior to screening, or planning to donate blood during the trial or within 1 month (30 days) after the trial. 17. Inability to avoid strenuous exercise for 14 days after drug administration. 18. History of substance abuse. 19. Pregnant or lactating women. 20. History of needle or blood phobia, poor venous access, or inability to tolerate venipuncture. 21. Any other condition deemed by the investigator to potentially compromise the participant's ability to complete the study or make them unsuitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PK endpoint indicators(Cmax, AUC0-t, AUC0-8, Tmax, t1/2, Vd/F, Kel, MRT, CL/F);Anti-Drug Antibody (ADA) Positivity Rate and Titer; | — |
Primary
| Measure | Time frame |
|---|---|
| Clinical Observation Indicators (Vital Signs, Physical Examination, 12-Lead Electrocardiogram, Chest X-ray);Laboratory test indicators (blood routine, urinalysis, blood biochemistry, coagulation routine);The incidence of local AEs, systemic AEs, and SAEs.;The incidence of local and systemic AEs.;Pharmacokinetic (PK) Endpoints; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Infectious Disease Hospital
Outcome results
None listed