elevated hsCRP and other biomarkers for inflammation
Conditions
Interventions
Product Name: VB-201
Product Code: VB-201
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: VB-201
CAS Number: 630112-41-3
Current Sponsor code: VB-201
Other descriptive name: CI 201
Concentrat
Sponsors
Vascular Biogenics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess and characterize the efficacy, safety and tolerability of VB-201. The effect of VB-201 compared to placebo(a ‘dummy treatment’ that looks like the VB-201 tablet but has no effect) will be observed while being administered at multiple doses ranging from 5mg to 240mg, for a duration of 4 weeks. The study will enroll 320 subjects with elevated high sensitivity C-Reactive Protein (hsCRP), a blood level that indicates you may have inflammation in your body. ;Secondary Objective: The secondary objective is to examine the effect of a 4 week treatment with different doses (5mg to 240mg) of VB-201 as compared with placebo (a ‘dummy treatment’) on inflammatory related biomarkers and RNA expression of inflammation related genes. The objective of the pharmacokinetic (PK)sub study is to assess the pharmacokinetics of VB-201 at the higher doses (120mg and 240mg).;Primary end point(s): Change from baseline of hsCRP levels. The change will be calculated as the difference between the average of 2 hsCRP sample determinations at screening (3-7 days apart) and the average of the 2 hsCRP determinations at week 4 (on day 25 and day 28). For PART B only, the change in hsCRP level will also be assessed at week 2 and week 8. | — |
Countries
United Kingdom
Outcome results
None listed