CTRI/2015/06/005838已完成2 期
A Randomized, double-blind, placebo controlled Phase I/II study to evaluate the safety, tolerability andneutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails) against rabies virus in healthy subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy male and female volunteers between 18 and 55 years of age
- •2. No previous treatment with rabies vaccine
- •3. Body Mass Index (BMI) between 20 and 25 kg/m2
排除标准
- •Pregnant women, women planning to become pregnant and breastfeeding
- •2. History and/or family history of clinically significant immunodeficiency or
- •auto-immune disease
- •3. History of allergy to proteins
- •4. Any clinically significant history of known or suspected anaphylaxis or
- •hypersensitivity reaction A history of or currently active clinically significant
- •cardiac (including clinically significant abnormalities on Electrocardiogram
- •[ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal,
- •hepatic, renal, pancreatic, or neurological disease
- •5. Abnormal hemoglobin, total WBC, RBC, platelets counts AST, ALT, serum
- •bilirubin, creatinine, BUN, fasting plasma glucose,
- •6. Subject taking any medications.
- •Prior history of active or passive rabies immunization
- •8. Clinically significant acute illness or infection within 2 weeks before first
- •dosing based on the clinical judgment of the investigator
- •9. Chronic administration of immunosuppressants or other immune-modifying
- •drugs within 6 months before the first dose of investigational medicinal product
- •10. History of untreated dog bites.
- •11. Subjects with detectable Rabies Vaccine Neutralizing Antibodies ( 0.1 IU/ml).
研究者
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