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

Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01159730
Collaborator
(none)
320
Enrollment
1
Location
2
Arms
12
Duration (Months)
26.7
Patients Per Site Per Month

Study Details

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
  • Drug: VB-201 or Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 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

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 VBL Investigative Site Glasgow Scotland United Kingdom

    Sponsors and Collaborators

    • Vascular Biogenics Ltd. operating as VBL Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vascular Biogenics Ltd. operating as VBL Therapeutics
    ClinicalTrials.gov Identifier:
    NCT01159730
    Other Study ID Numbers:
    • VB-201-030
    First Posted:
    Jul 9, 2010
    Last Update Posted:
    Nov 16, 2011
    Last Verified:
    Nov 1, 2011

    Study Results

    No Results Posted as of Nov 16, 2011