A phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers

ISRCTN ISRCTN18660493
DOI https://doi.org/10.1186/ISRCTN18660493
Secondary identifying numbers RAB-M-A001
Submission date
27/03/2007
Registration date
10/05/2007
Last edited
01/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Kissling
Scientific

MDS Pharma Servces
621 Rose Street
Lincoln
NE68502
United States of America

Study information

Study design1: 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 designInterventional
Secondary study designCohort study
Study setting(s)Not specified
Study typeTreatment
Scientific titleA phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Study objectivesFirst time in human study of CL184, a human monoclonal antibody cocktail against rabies virus.
Ethics approval(s)Approval received from the MDS Pharma Services Institutional Review Board on the 22nd November 2006.
Health condition(s) or problem(s) studiedRabies
InterventionPart 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)CL184
Primary outcome measureSafety and tolerability: this is assessed throughout the study, i.e., over 42 days.
Secondary outcome measures1. 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 study start date06/12/2006
Completion date18/05/2007

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment57
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/12/2006
Date of final enrolment18/05/2007

Locations

Countries of recruitment

  • United States of America

Study participating centre

MDS Pharma Servces
Lincoln
NE68502
United States of America

Sponsor information

Crucell Holland BV (The Netherlands)
Industry

Archimedesweg 5
Leiden
2333 CN
Netherlands

Website http://www.crucell.com
ROR logo "ROR" https://ror.org/04cxegr21

Funders

Funder type

Industry

Crucell Holland BV (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 05/11/2008 01/09/2021 Yes No

Editorial Notes

01/09/2021: Publication reference and total final enrolment added.