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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01159730
Other study ID # VB-201-030
Secondary ID
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


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, 

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