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

Phase 2

Completed

• Conditions: Biomarker
• Interventions: Drug: VB-201 or Placebo

• Registration Number: NCT01159730
• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Study Start: 2010-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple doses of VB-201	VB-201 or Placebo	-
Placebo	VB-201 or Placebo	-

Trial Locations

Locations (1)

VBL Investigative Site; 🇬🇧 Glasgow, Scotland, United Kingdom