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
Protocol serial number	RAB-M-A001
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 James Kissling
Scientific

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

Primary study design	Interventional
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
Secondary study design	Cohort study
Scientific title	A phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Study objectives	First 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) studied	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 / 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	18/05/2007

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	60
Total final enrolment	57
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 20 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	06/12/2006
Date of final enrolment	18/05/2007

MDS Pharma Servces

Lincoln
NE68502
United States of America

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		05/11/2008	01/09/2021	Yes	No

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