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

November 15, 2011 updated by: Vascular Biogenics Ltd. operating as VBL Therapeutics

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • VBL Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: VB-201 or Placebo
EXPERIMENTAL: Multiple doses of VB-201
Drug: VB-201 or Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (ESTIMATE)

July 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • VB-201-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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