To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people
Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
Men or women aged 18~50 (including boundary values) at the time of screening;
The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical contraception, while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.
Those who are known to be allergic to the study drug (including excipients, similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);
Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);
Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
Parallel
Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg
DrugActive ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg
DrugActive ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
Rabies Human Immunoglobulin (HRIG)
DrugActive ingredient: Rabid human immunoglobulin
Lyophilized rabies vaccine for human use (Vero cells)
Biological/VaccineActive ingredient: inactivated rabies virus fixed poison
Rabia for neutralizing antibody activity
Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication.
Rabia for neutralizing antibody activity
RVNA detection rate at days 0.5,1,2,3,5,7,14,28,42,84, and 105 after drug administration. Geometric mean concentration and relative antibody positive rate at days 0.5,1,2,3,5,105,28,42,84,105 (RVNA 0.5 IU / ml).
Safety evaluation index
Clinical indicators:Physical examination.
Safety evaluation index
Vital signs: ear temperature/℃
Safety evaluation index
Vital signs: blood pressure (sitting position)/mmHg
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Changchun BCHT Biotechnology Co.
Lead sponsor
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Collaborator
Anning City First People's Hospital
Collaborator
Yunnan Central Hospital
Collaborator
Beijing Contreke Statistical Technology Co., LTD
Collaborator
Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
