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.
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Treatment groupsSee each treatment group below.