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Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers

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ClinicalTrials.gov Identifier: NCT01159730
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.

Condition or disease Intervention/treatment Phase
Biomarker Drug: VB-201 or Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers
Study Start Date : October 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: Multiple doses of VB-201 Drug: VB-201 or Placebo
Placebo Comparator: Placebo Drug: VB-201 or Placebo


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, ≥18 to ≤75 years of age;

Exclusion Criteria:

  • Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
  • 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);
  • Subjects with a history of coronary events within the last 6 months;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159730


Locations
United Kingdom
VBL Investigative Site
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
More Information

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01159730     History of Changes
Other Study ID Numbers: VB-201-030
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011