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

Biomarker Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159730
• Other study ID #: VB-201-030
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2010
• Last updated: November 15, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Biomarker

Intervention

Drug:
• VB-201 or Placebo

Locations

Country	Name	City	State
United Kingdom	VBL Investigative Site	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Country where clinical trial is conducted

United Kingdom,