Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
- Registration Number
- CTRI/2011/10/002060
- Lead Sponsor
- Crucell Holland bv
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
Male or female subject aged greater or equal to 18 years to less or equal to 55 years
Subjects free of obvious health-problems or with stable conditions or medications
Body mass index between greater or equal to 18 to less or equal 30 kg/m2
Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
Male subjects must agree that they will not donate sperm from the first check-in until Day 90
Subject signed written informed consent
Prior history of active or passive rabies immunization
Clinically significant acute illness or infection including fever (greater or equal to 38 C) within 2 weeks before first dosing
History and/or family history of clinically significant immunodeficiency or auto-immune disease
Planned immunization with live vaccines during the coming 3 months after first dosing
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with adverse events as a measure of safetyTimepoint: 90 days
- Secondary Outcome Measures
Name Time Method Rabies virus neutralizing activityTimepoint: 90 days