Condition category
Infections and Infestations
Date applied
10/05/2007
Date assigned
22/06/2007
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 Pramod Kabra

ORCID ID

Contact details

Dhirubhai Ambani Life Sciences Centre (DALC)
Plot R-282
TTC Area of MIDC
Rabale
Navi
Mumbai
400 701
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RAB-M-A002

Study information

Scientific title

Acronym

Study hypothesis

First time in Asian subjects study of CL184, a human monoclonal antibody cocktail against rabies virus.

Ethics approval

Received from 'Ethics R'US', based in Mumbai (India).

Study design

Randomised, double-blind, placebo controlled, phase Ib study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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 0 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/II

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

02/04/2007

Overall trial end date

08/07/2007

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 18 and 28 kg/m^2

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

44

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

02/04/2007

Recruitment end date

08/07/2007

Locations

Countries of recruitment

India

Trial participating centre

Dhirubhai Ambani Life Sciences Centre (DALC)
Mumbai
400 701
India

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