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
Protocol serial number	RAB-M-A002
Sponsor	Crucell Holland BV (The Netherlands)
Funder	Crucell Holland BV (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Pramod Kabra
Scientific

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

Primary study design	Interventional
Study design	Randomised, double-blind, placebo controlled, phase Ib study
Secondary study design	Randomised controlled trial
Scientific title	A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Study objectives	First 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) studied	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 / device / biological / vaccine name(s)	CL184
Primary outcome measure(s)	Safety and tolerability: this is assessed throughout the study, i.e., over 42 days.
Key secondary outcome measure(s)	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
Completion date	08/07/2007

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	44
Total final enrolment	44
Key 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
Key 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
Date of first enrolment	02/04/2007
Date of final enrolment	08/07/2007

Dhirubhai Ambani Life Sciences Centre (DALC)

Mumbai
400 701
India

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		17/09/2008	01/09/2021	Yes	No

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