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

ISRCTN ISRCTN12693237
DOI https://doi.org/10.1186/ISRCTN12693237
Secondary identifying numbers RAB-M-A002
Submission date
10/05/2007
Registration date
22/06/2007
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 Pramod Kabra
Scientific

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

Study information

Study designRandomised, double-blind, placebo controlled, phase Ib study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Study objectivesFirst time in Asian subjects study of CL184, a human monoclonal antibody cocktail against rabies virus.
Ethics approval(s)Received from 'Ethics R'US', based in Mumbai (India).
Health condition(s) or problem(s) studiedRabies
InterventionPart 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
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 date02/04/2007
Completion date08/07/2007

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants44
Total final enrolment44
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 18 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 enrolment02/04/2007
Date of final enrolment08/07/2007

Locations

Countries of recruitment

  • India

Study participating centre

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

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 17/09/2008 01/09/2021 Yes No

Editorial Notes

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