A Phase II, Single-Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody Injection in Healthy Subjects
Healthy individuals aged 18-60 years (inclusive), regardless of gender, capable of providing valid legal identification.
Participants voluntarily agree to participate in the study and sign an informed consent form.
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 adopt effective physical contraceptive measures. Male participants must have no plans for pregnancy or sperm donation within 6 months after dosing and must voluntarily adopt effective physical contraceptive measures.
Female participants must weigh ≥45.0 kg and ≤80.0 kg, and male participants must weigh ≥50.0 kg and ≤80.0 kg. Body mass index (BMI) must be between 18.0 and 26.0 kg/m² (inclusive) (BMI = weight in kg / height in m²).
Known allergy to the investigational product (including excipients or similar drugs), or individuals with a history of severe allergic diseases or considered allergic constitution (e.g., allergies to two or more drugs, foods, or pollen) as judged by the investigator to potentially compromise participant safety.
Clear history of allergy to essential substances that may be encountered during the trial (e.g., skin disinfectants).
History of clinically severe diseases within the 6 months (180 days) prior to screening that remain unresolved, or current acute or chronic illnesses that may significantly affect the metabolism or safety evaluation of the investigational product.
History of autoimmune diseases or chronic hepatitis.
Parallel
Recombinant Human Rabies Virus Monoclonal Antibody Injection
DrugOn Day 0, administer via intramuscular injection into the lateral thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to co-administer at the same injection site.
Human Rabies Immunoglobulin (HRIG)
DrugOn Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
Placebo
DrugOn Day 0, administration shall be performed via intramuscular injection into the lateral aspect of the thigh. It is strictly prohibited to use the same syringe as the rabies vaccine or to administer both agents at the same injection site.
Rabies Vaccine
Biological/VaccineOn Days 0, 3, 7, 14, and 28, administer via intramuscular injection into the deltoid muscle of the upper arm. Injection into the gluteal region is prohibited. The injection on Day 0 should be administered as soon as possible after the administration of the investigational product.
7
Treatment groupsSee each treatment group below.
Occurrence of any local and systemic adverse events (AEs) within at least 30 minutes after administration of the investigational product/vaccine.
Local and systemic adverse events (AEs)
Occurrence of any local AEs, systemic AEs, and serious adverse events (SAEs) from the administration of the investigational product on Day 0 until the last visit.
Local AEs, systemic AEs, and serious adverse events (SAEs)
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Tympanic temperature（℃）
Vital signs changes from baseline at different observation time points following the administration of the investigational product/vaccine.
Systolic Pressure and Diastolic Pressure (Sitting Position) （mmHg）
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Cmax.
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: AUC0-t.
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: AUC0-∞.
Pharmacokinetic Endpoints
The concentrations of LZR08 and LZR07 antibodies in serum were measured within 1 hour before the administration of the investigational product on Day 0 and at 12 hours, 1 day, 2 days, 3 days, 5 days, 7 days, 10 days, 14 days, 28 days, 42 days, 56 days, 84 days, and 105 days after the administration of the investigational product/vaccine. The following pharmacokinetic (PK) endpoints were calculated: Tmax.
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