CTRI/2012/12/003225已完成1 期
A Randomized, double-blind, placebo controlled multicentric Phase I/II study to evaluate the safety, tolerability and neutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails)against rabies virus in healthy subjects
Zydus Research Centre0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •1. 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
- •1. Pregnant women, women planning to become pregnant and breastfeeding women
- •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
- •7. 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
研究者
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