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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01159730
First received: July 8, 2010
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Biomarker
 Drug: VB-201 or Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Estimated Enrollment: 320
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple doses of VB-201 Drug: VB-201 or Placebo
Placebo Comparator: Placebo Drug: VB-201 or Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159730

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

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01159730     History of Changes
Other Study ID Numbers: VB-201-030
Study First Received: July 8, 2010
Last Updated: November 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on May 16, 2013