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| Name | Class |
|---|---|
| The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | UNKNOWN |
| Anning City First People's Hospital | UNKNOWN |
| Beijing Contreke Statistical Technology Co., LTD | UNKNOWN |
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rabies mab CBB 1 is mainly used for passive immunization of patients bitten or scratched by rabies or other animals carrying rabies virus, this study mainly studies the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenic characteristics of rabies mAb CBB 1 in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Natural full human monoclonal antibody CBB 1 injection:Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart. |
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| Positive control group | Active Comparator | Rabies Human Immunoglobulin (HRIG) Active ingredient: Rabid human immunoglobulin Specification: 200 IU / 2 ml / bottle Administration mode: intramuscular injection of the vastus lateral muscle group. Usage and dosage: the injection dose was calculated according to the body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site and at least 2.5 cm apart |
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| Placebo group | Placebo Comparator | Healthy people in placebo group will receive a dose of placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural full human monoclonal antibody CBB 1 injection | Drug | Active 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation index | All observed adverse events, serious adverse events, including but not limited to: Clinical indicators Physical examination; vital signs; 12-lead ECG; local reaction; systemic reaction. Laboratory indicators Laboratory tests: blood routine, urine routine, blood biochemistry (including liver function, fasting blood glucose, renal function, blood lipid, myocardial enzyme spectrum and electrolyte), blood coagulation routine, viral serology (hepatitis B two half, hepatitis C virus antibodies, human immunodeficiency virus antibodies and treponema antibodies), blood / urine pregnancy test (fertility only women); other auxiliary tests: chest radiograph (positive) and abdominal B ultrasound (including liver, gallbladder, pancreas, spleen and kidney). | Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| PK evaluation index | (1) PK evaluation index Peak Plasma Concentration (Cmax) | Twelve months |
| PK evaluation index | (1) PK evaluation index Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | Kunming | Yunnan | 650000 | China |
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| Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD | UNKNOWN |
There were 152 healthy people aged 10-50 years, divided into two test groups: 76 rabies mAb CBB 1 alone and 76 rabies mAb CBB 1 combined with rabies vaccine administration, which were divided into 4 groups according to different doses
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The design of this trail is based on random, two-blind, placebo control. The subjects and investigators will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
| Rabies Human Immunoglobulin (HRIG) | Drug | Active ingredient: Rabid human immunoglobulin |
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| Natural full human monoclonal antibody CBB 1 injection placebo | Drug | Composition: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection |
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| Lyophilized rabies vaccine for human use (Vero cells) | Biological | Active ingredient: inactivated rabies virus fixed poison |
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| Twelve months |
| PK evaluation index | (1) PK evaluation index Maximum peak time (Tmax) | Twelve months |
| PK evaluation index | (1) PK evaluation index Half-life period(T1/2) | Twelve months |
| PK evaluation index | (1) PK evaluation index MeanResidenceTime(MRT) | Twelve months |
| PK evaluation index | (1) PK evaluation index Apparent clearance rate (CL / F) | Twelve months |
| PD evaluation index | (2) PD evaluation index Positive rate of RVNA antibody on days 1,3,5,7,14,28 and 42 after medication (percentage of GMT 0.5 IU / ml volunteers); Neutralising antibody (RVNA) activity at days 0.5,1,2,3,5,7,10,14,1,21,28,42,56,84 and 105 after administration. | Twelve months |
| Immunogenicity evaluation index | (3) Immunogenicity evaluation index ADA positivity on days 14,28,56 and 105 after administration. If ADA positive, they will continue to be evaluated as rabies mAb CBB 1 neutralizing antibody. | Twelve months |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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