Condition category
Infections and Infestations
Date applied
27/03/2007
Date assigned
10/05/2007
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Kissling

ORCID ID

Contact details

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

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

http://www.crucell.com

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

Publication citations

Additional files

Editorial Notes