to evaluate the safety, tolerability and neutralizing activity of Rabimabs against rabies virus in healthy subjects

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003225

Enrollment

Registered

2012-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rabimab Vaccine: RABIMABS will be available in 300 IU/mL. Each vial will contain 10ml of the solution. RABIMABS is equipotent mixture of two M777-16-3 and MAb 62-71-3 in 1:1 ratio. RAB

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Safety and tolerability 2. Pharmacokinetics (PK) after Intra muscular dose administrations in healthy adult volunteers 3. Pharmacodynamic (PD) effect after Intra muscular dose administrations in healthy adult volunteers Timepoint: day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration.	—

Secondary

Measure	Time frame
1. RABIMABS (Part 1 ) 2. RVNA of human origin (Part 1& 2) 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.	—

Countries

India

Contacts

Public ContactDr R H Jani

Cadila Healthcare Limited

rhjani@zyduscadila.com02226186052

Outcome results