None listed
Conditions
Interventions
Intervention1: RABIMABS in conjunction with Zydus rabies vaccine(Vaxirab): For Rabimab :Dosage:-40 IU/kg
Route:intramuscularly
Frequency:Once
Duration:-Once
For Vaxirab,
Dosage:1ml
Route:intramuscular
Sponsors
Cadila HealthCare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Vitals, Laboratory Parameters) 2. Injection site reaction 3. Body temperatureTimepoint: Vitals:Vitals will be taken during predose and 0.25, 0.5, 1.00, 2.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours after dosing of Rabimabs, Day 07,Day 14,Day 21,Day 28,Day Lab Safety Assessment:-Screening,Day 07, day 42. ECG:-Screening,24 hours after dosing,Day 07,Day 28,Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| RVNA (Rabies virus neutralization assay) of human origin Virus neutralization activity of Rabimabs by Rapid Fluorescent Focus Inhibition Test(RFFIT) by bioassay. and Human anti RABIMABS antibodies (Immunogenicity of Rabimabs (M777-16-3 and MAb 62-71-3) by ELISA method.Timepoint: Screening,Day 07,24 hrs after Dosing,Day 14,Day 21,Day 28,Day 42. | — |
Countries
India
Contacts
Public ContactDr KevinKumar Kansagra
Zydus Research Centre
Outcome results
None listed