rabies
Conditions
Interventions
SYN023 administration group:SYN023 Multiple Muscle Injections
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 60 years old on the day of enrolment, regardless of sex. 2. Have a clear history of rabies exposure within 6 months prior to enrolment. 3. The subject's clinical manifestation of rabies (manic or paralytic) was <24 hours from the time of signing the informed consent form. 4. I, and my authorised representative, agree to participate in the study and voluntarily assume the risks of safety, lack of efficacy, and poor prognosis by accepting the therapeutic regimen of the study. 5. I and my authorised representative fully understand and sign the informed consent form. 6. I am in a clear state of mind and all vital sign measurements are normal or abnormal but not clinically significant.
Exclusion criteria
Exclusion criteria: 1. Muscle weakness or paralysis within 3 days prior to enrolment. 2. Organ or circulatory failure or shock within 3 days prior to enrolment. 3. Previous history of severe allergy, such as generalised urticaria, allergic laryngeal oedema, anaphylactic purpura, local anaphylactic necrotic reaction (Arthus reaction), angioneurotic oedema, anaphylactic shock, etc.; or known allergy to any of the ingredients contained in the test drug. 4. Have suffered or currently suffer from any systemic disease or poorly controlled chronic disease that, in the opinion of the investigator, may interfere with the assessment of safety or efficacy, including, but not limited to, haematological disorders, hepatic and renal disorders, gastrointestinal disorders, respiratory disorders, malignant neoplasms, and history of transplantation of major functional organs. 5. Previous or current neurological or psychiatric disorders. 6. Other conditions that the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: Adverse reactions and serious adverse events within 5 days after medication;Efficacy endpoint: Survival rate on the 5th day after medication administration; | — |
Countries
China
Contacts
Public ContactSi Liu
Peking University First Hospital
Outcome results
None listed