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

NCT ID: NCT01159730

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biomarker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multiple doses of VB-201

Group Type EXPERIMENTAL

VB-201 or Placebo

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

VB-201 or Placebo

Intervention Type DRUG

Interventions

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VB-201 or Placebo

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vascular Biogenics Ltd. operating as VBL Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VBL Investigative Site

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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VB-201-030

Identifier Type: -

Identifier Source: org_study_id