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
1. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity of rabies virus after single doses of rabies mAb CBB 1 or rabies human immunoglobulin (HRIG) in healthy adults. 2. Evaluate and compare the safety, tolerability, pharmacokinetics, neutralizing antibody activity and immunogenicity characteristics of rabies virus after different doses of rabies mAb CBB 1 combination vaccine or HRIG combination vaccine in healthy adults. 3. Comparison of different doses of rabies mAb CBB 1 alone, different doses of rabies mAb CBB 1, combination vaccine or HRIG combination vaccine used in healthy adults after safety, tolerability, pharmacokinetics, rabies virus neutralization antibody activity and immunogenicity characteristics, further evaluation of drug interaction, for subsequent clinical trials to explore the optimal dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
152
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
Active ingredient: Rabid human immunoglobulin
Composition: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Kunming, Yunnan, China
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).
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index Peak Plasma Concentration (Cmax)
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index Area under the plasma concentration versus time curve (AUC)
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index Maximum peak time (Tmax)
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index Half-life period(T1/2)
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index MeanResidenceTime(MRT)
Time frame: Twelve months
PK evaluation index
(1) PK evaluation index Apparent clearance rate (CL / F)
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Active ingredient: inactivated rabies virus fixed poison
Time frame: 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.
Time frame: 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.
Time frame: Twelve months