Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RAB-M-A001
Study information
Scientific title
Acronym
Study hypothesis
First time in human study of CL184, a human monoclonal antibody cocktail against rabies virus.
Ethics approval
Approval received from the MDS Pharma Services Institutional Review Board on the 22nd November 2006.
Study design
1: three cohorts of subjects receive CL184 versus placebo, with increased doses in each cohort
2: one cohort of subjects receive CL184 in combination with rabies vaccine in an open label design
Primary study design
Interventional
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rabies
Intervention
Part 1: The study subjects will receive one dose of CL184 intramuscularly at Day zero and will be followed up over 42 days.
Part 2: The study subjects will receive one dose of CL184 on Day 0 in combination with rabies vaccine on Days 0, 3, 7, 14 and 28
Intervention type
Drug
Phase
Phase I
Drug names
CL184
Primary outcome measures
Safety and tolerability: this is assessed throughout the study, i.e., over 42 days.
Secondary outcome measures
1. Neutralising activity: this analysis is made at Day 14 and at all other timepoints up to Day 42.
2. Pharmacokinetics of CL184: this is a time-dependent parameter and analysis is performed over the full study duration, i.e., 42 days.
Overall trial start date
06/12/2006
Overall trial end date
18/05/2007
Reason abandoned
Eligibility
Participant 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 20 and 28 kg/m^2
Participant type
Healthy volunteer
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant 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
Recruitment start date
06/12/2006
Recruitment end date
18/05/2007
Locations
Countries of recruitment
United States of America
Trial participating centre
MDS Pharma Servces
Lincoln
NE68502
United States of America
Sponsor information
Organisation
Crucell Holland BV (The Netherlands)
Sponsor details
Archimedesweg 5
Leiden
2333 CN
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Crucell Holland BV (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary