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 |
| Secondary identifying numbers | RAB-M-A001 |
- Submission date
- 27/03/2007
- Registration date
- 10/05/2007
- 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 James Kissling
Scientific
Scientific
MDS Pharma Servces
621 Rose Street
Lincoln
NE68502
United States of America
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | CL184 |
| Primary outcome measure | 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 study start date | 06/12/2006 |
| Completion date | 18/05/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- United States of America
Study participating centre
MDS Pharma Servces
Lincoln
NE68502
United States of America
NE68502
United States of America
Sponsor information
Crucell Holland BV (The Netherlands)
Industry
Industry
Archimedesweg 5
Leiden
2333 CN
Netherlands
| Website | http://www.crucell.com |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 05/11/2008 | 01/09/2021 | Yes | No |
Editorial Notes
01/09/2021: Publication reference and total final enrolment added.
