A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Phase 1
Completed
- Conditions
- RabiesInfections and Infestations
- Registration Number
- ISRCTN12693237
- Lead Sponsor
- Crucell Holland BV (The Netherlands)
- Brief Summary
2008 Results article in https://pubmed.ncbi.nlm.nih.gov/18804136/ (added 01/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
1. Healthy volunteers between 19 and 55 years of age
2. No previous treatment with rabies vaccine
3. Body Mass Index (BMI) between 18 and 28 kg/m^2
Exclusion Criteria
1. Pregnant women, women planning to become pregnant and breastfeeding women
2. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability: this is assessed throughout the study, i.e., over 42 days.
- Secondary Outcome Measures
Name Time Method <br> 1. Neutralising activity: this analysis is made at Day 14 and at all other timepoints up to day 42<br> 2. Pharmacokinetics of CL184: this is a time-dependent parameter and analysis is performed over the full study duration, i.e., 42 days<br>