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. - A 4 wk treatment with multiple doses of VB-201 to examine hsCRP levels

Conditions: elevated hsCRP and other biomarkers for inflammation

Registration Number: EUCTR2010-020783-38-GB

Lead Sponsor: Vascular Biogenics Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

1)Fully understand all elements of and have signed and dated the written Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
2)Male or female patients, =18 to =75 years of age;
3)Subjects who have a screening hsCRP level between 2 mg/L - 10 mg/L on 2 separate tests (3-7 days apart);
4)Subjects must be on a stable high dose of statin for at least 3 months prior to screening including either atorvastatin =20 mg /day or rosuvastatin =10 mg /day or simvastatin =40mg/day;
5)For a female subject; either:
- subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy
or
- agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
Males must use at least one method of contraception (e.g.,
condom) throughout the study;
6)In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Subjects receiving systemic corticosteroid or biologic anti-inflammatory therapy;
2)Received any investigational drug within 30 days of screening;
3)The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator’s Brochure);
4)Any other acute or chronic medical condition that, in the opinion of the investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study;
5)Diagnosis of an inflammatory condition known to affect CRP such as Rheumatoid arthritis, Multiple sclerosis, Inflammatory Bowl disease, Psoriasis etc.
6)Subjects with any laboratory test at screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal:
•alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase ³1.5 times the upper limit of normal (ULN) or
•cytopenia (to include any of the following: WBC <3.5´103/µL; Hgb <10 g/dL; platelets <120´103/µL; neutrophils absolute <1.5´103/µL; lymphocytes absolute <0.8´103/µL) or
•Creatinine ³1.25 times the upper limit of normal (ULN);
If, in the investigator’s opinion, there is no reason for the test result(s) to be abnormal, the abnormal test(s) may be repeated once during the screening period;
7)Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
8)Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis);
9)Subjects with a history of coronary events within the last 6 months;
10)Subjects presenting with HbA1c > 8.5 % within 3 months of screening;
11)History of substance abuse, including alcohol abuse, within the past year;
12)Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; Subjects with depression that has been adequately controlled for at least 6 months may enroll in the study].