A 4 wk treatment with multiple doses of VB-201 to examine hsCRP levels
Research type
Research Study
Full title
A Phase II, Randomised, Double blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers of Inflammation, Safety and Pharmacokinetics in Subjects with Elevated High Sensitivity C-Reactive Protein.
IRAS ID
55551
Contact name
John Robinson
Sponsor organisation
Vascular Biogenics Ltd
Eudract number
2010-020783-38
Clinicaltrials.gov Identifier
Research summary
This study will assess the efficacy, safety and tolerability of VB-201. Approximately 320 subjects will receive VB-201 at doses ranging between 5mg to 240mg or they will receive a placebo (a ??dummy treatment?? that looks like the VB-201 tablet but has no effect), for a duration of 4 weeks. Subjects will be male or female, aged 18-75 years with an elevated high sensitivity C-Reactive Protein (hsCRP) level and who are already being treated with statins. The elevated high sensitivity C-Reactive Protein is a blood level that indicates patients may have inflammation in their body. The protocol will include 2 parts, Part A and Part B. In part A, subjects will be assigned to receive either 5mg, 20mg, 40mg, 80mg, of VB-201 or placebo (a ??dummy treatment??). In part B, patients will receive either 120mg, 240mg of VB-201 or placebo (a ??dummy treatment??), subject who consent to Part B will also be asked to consent to a Pharmacokinetic sub study. Elevated high sensitivity C-Reactive Protein (hsCRP) is a known biomarker of inflammation, VB-201 has been found to have anti inflammatory effects in various inflammatory related diseases.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
10/H0605/51
Date of REC Opinion
29 Sep 2010
REC opinion
Further Information Favourable Opinion