to evaluate the safety, tolerability and neutralizing activity of Rabimabs against rabies virus in healthy subjects
- Registration Number
- CTRI/2012/12/003225
- Lead Sponsor
- Zydus Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety and tolerability <br/ ><br>2. Pharmacokinetics (PK) after Intra muscular dose administrations in healthy adult volunteers <br/ ><br>3. Pharmacodynamic (PD) effect after Intra muscular dose administrations in healthy adult volunteers <br/ ><br>Timepoint: day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. RABIMABS (Part 1 ) <br/ ><br>2. RVNA of human origin (Part 1& 2) <br/ ><br>3. Human anti-RABIMABS antibodies (Part 1& 2)Timepoint: day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration. <br/ ><br>