Prevention after exposure to suspected rabies virus
Conditions
Interventions
Group 1:GR1801 injection 0.00625mg/kg
Group 2:GR1801 injection 0.0125mg/kg
Group 3:GR1801 injection 0.025mg/kg
Group 4:human rabies immune globulin 20IU/kg
Group 5:GR1801 injection 0.05mg/kg
Sponsors
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Before the trial, Having known the property, significance, possible benefits, possible inconvenience and potential risks and discomforts of the trial in detail, and volunteer to participate in this clinical trial, be able to communicate well with the investigator, and comply with the requirements of the entire trial , And sign a written informed consent form; (2) Males or females aged between 18 and 45 (including the boundary value) at the time of screening; (3) The weight of male volunteers is =50.0kg and =80.0 Kg, the weight of female volunteers is =45.0kg and =80.0 Kg, and the body mass index (BMI) is 18.0~27.0 kg/m2 (including boundary values); (4) Female volunteers have no plans to give birth or donate ovum within 14 days before the administration to 6 months after the end of the administration, and voluntarily take effective physical contraceptive measures, and the male volunteers have no plans to give birth or donate sperm within 6 months after the end of administration,voluntarily take effective physical contraceptive measures; (5) According to the results of physical examination, vital signs, electrocardiogram, clinical laboratory examination and other auxiliary examinations during the screening period, combining with previous medical history, the investigator judges that all examination results are normal or abnormal but have no clinical significance.
Exclusion criteria
Exclusion criteria: (1) Those who are known to be allergic to investigational drugs (including excipients and similar drugs), or suffer from severe allergic diseases or are allergic constitution(such as allergic to two or more drugs, food or pollen), the investigator judges that the safety of volunteers may be compromised; (2) Those who have a definite history of allergies to essential substances (such as skin disinfectants) that may be exposed during the trial; (3) Suspected or comfirmed injury history from warm-blooded mammal in the last 12 months (360 days); (4) A prior history of autoimmune diseases; (5) A history of active infection or disease; (6) Having a history of active tuberculosis or active tuberculosis infection during the screening period; (7) Having a history of malignant tumor; (8) Having a history of convulsions, epilepsy and other mental or neurological diseases, or having a family medical history of convulsions or epilepsy; (9) Having a history of serious clinical diseases and have not been cured within 6 months (180 days) before the administration of the drug, or who are currently suffering from acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the investigational drug; (10) Having received major surgery within 3 months (90 days) before the administration of the drug or plan to receive major surgery during the trial, and the researcher judges that it may significantly affect the in vivo process or safety evaluation of the study drug; (11) Prior vaccination against human rabies vaccine ; (12) Those who have used rabies passive immunity preparations or use of glucocorticoids systematacially within 3 months (90 days) before administration of the drug; (13) Having received vaccines other than rabies vaccine within 3 months (90 days) before administration of the drug; (14) Those who have used other investigational drug within 3 months(90 days)before the administration of the drug or plan to participated in other clinical trials during the trial; (15) Those who have used or are using drugs that may have a significant impact on the in vivo process or safety evaluation of the drug in this trial within 14 days before the administration of the drug; (16) Having a history of substance abuse; (17) Being tested positive for substance abuse during screening; (18) Those who lost or donated more than 300 mL of blood within 3 months (90 days) before administration of the drug(except for female physiological blood loss), or who have received blood transfusion or have used blood products, or who planned to donate blood during the trial period or 1 month(30 days) after the end of the trial; (19) Smoking more than 10 cigarettes or equivalent amount of tobacco per day within 1 month (30 days) before administration of the drug; (20) Patients who drank alcohol frequently within 3 months (90 days) before administration of the drug, or who could not abstain from alcohol during the trial; (21) Those who had a positive alcohol breath test or a test value> 0 mg/100 mL during screening; (22) The abnormal 12-lead ECG results have clinical significance judged by the investigator during screening; (23) Abnormal physical examination and vital signs have clinical significance judged by the investigator during screening; (24) Abnormal laboratory examinations or other auxiliary examination results have clinical significance judged by the investigator during screening; (25) Positive for hepatitis B su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index (clinical observation index, laboratory test index, immunogenicity evaluation index); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of volunteers with rabies virus neutralizing antibody activity (RVNA) =0.5 IU/mL;RVNA relative antibody positive rate (Percentage of volunteers with rabies virus neutralizing antibody activity RVNA =0.5 IU/mL);RVNA geometric mean titer;PK evaluation index;RVNA geometric mean titer; | — |
Countries
China
Contacts
Public ContactJianchang He
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Outcome results
None listed