PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Tue, 13 Nov :59:14 GMT) CTRI Number Last Modified On 14/09/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/12/ [Registered on: 17/12/2012] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group, Placebo Controlled Trial 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Rabimabs 1001 Ver. 1.1 Dated 02/5/2012 Protocol Number Details of Principal Investigator Dr Kevin Kumar Kansagra Scientist Zydus Research Centre Phone Fax Zydus Research Centre, -- Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Ahmadabad Ahmadabad kevinkumarkansagra@zyduscadila.com Details Contact Person (Scientific Query) Dr R H Jani Sr V P Cadila Healthcare Limited Phone Fax Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East) Mumbai MAHARASHTRA Mumbai MAHARASHTRA rhjani@zyduscadila.com Details Contact Person (Public Query) Dr R H Jani Sr V P Cadila Healthcare Limited Zydus Cadila House, 2nd floor, Plot No.360,T.P.S. 5, Service road, Vile Parle (East) Mumbai MAHARASHTRA MAHARASHTRA page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone Fax rhjani@zyduscadila.com Source of Monetary or Material Support > Zydus Research Centre 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad Type of Sponsor NIL List of Countries of Principal Investigator Dr Kevibkumar Kansagra Primary Sponsor Details Zydus Research Centre 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Zydus Research Centre 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya Cadila Healthcare Limited Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing Ahmadabad Ahmadabad kevinkumarkansagra@ zyduscadila.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Independent Ethics Co Approved 08/08/2012 Yes mmittee-aditya,ahmeda bad Status Date Approved/Obtained 08/08/2012 Health Type Healthy Human Volunteers Condition to evaluate the safety, tolerability and neutralizing activity of Rabimabs against rabies virus in healthy subjects Type Details Intervention Rabimab Vaccine RABIMABS will be available in 300 IU/mL. Each vial will contain 10ml of the solution. RABIMABS is equipotent mixture of two M and MAb in 1:1 ratio. RABIMABS binds to 2 different epitopes on the G-protein of the rabies virus envelope. One milliliter of Zydus rabies vaccine (Vaxirab) will be injected into page 2 / 5

3 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Comparator Agent NA NA Age From Age To Gender Details Details Year(s) Year(s) Both Computer generated randomization Inclusion Criteria the deltoid muscle (contra lateral to RABIMABS or placebo). Frequency-Single dose 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 Sequentially numbered, sealed, opaque envelopes Not Applicable 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 Primary Outcome Outcome Timepoints 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 day 0, and on days 1, 2, 3, 7, 14, 21, 28, and 42 following drug administration. Secondary Outcome Outcome Timepoints Target Sample Size 1. RABIMABS (Part 1 ) day 0, and on days 1, 2, 3, 7, 14, 21, 28, and RVNA of human origin (Part 1& 2) following drug administration. 3. Human anti-rabimabs antibodies (Part 1& 2) Total Sample Size=24 Sample Size from =24 page 3 / 5

4 Phase of Trial Phase 1/ Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 17/12/2012 No Date Specified Years=0 Months=1 Days=12 Not Applicable Completed NA Rabies is an acute fatal encephalomyelitis and remains one of the most feared and dreadful zoonotic diseases in the world. According to WHO estimate, Rabies occurs in more than 150 countries and territories. More than people die off Rabies every year. 40% of people who are beaten by suspected rabid animals are children under 15 years of age. More than 3 billions live in areas in which the disease is an enzootic. Once the clinical signs and symptoms develop, Rabies is almost invariably fatal.the anti-rabies monoclonal antibody cocktail drug being developed at Zydus Research Center, Cadila Healthcare Ltd. is a unique combination of two murine anti-g monoclonal antibodies (MAbs) selected from a panel of five MAbs shortlisted by WHO from collaborating research centres around the world, that bind to two different epitopes on the G protein expressed on the surface of Rabies virus. From panels of anti-rabies Mabs available through its collaborating centers, WHO had initially selected a smaller panel of five murine anti-g MAbs on the basis of their ability to neutralise a broad range of rabies viruses and their heavy chain isotype, selected to be either IgG1 or IgG2a. From this shortlisted panel of WHO, Zydus selected two monoclonals primarily on the basis of their ability to bind two different epitopes on the G protein, and secondarily on the basis of the phenotypic stability of the clone, ability to grow in bioreactors, ability for scalability of the clone, expression levels of page 4 / 5

5 Powered by TCPDF ( PDF of Trial the clone etc. This is an 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 The objectives are to evaluate the safety, tolerability and neutralizing activity of Rabimabs (A murine anti-rabies monoclonal antibody cocktails) against rabies virus in healthy subjects. page 5 / 5