NCT01159730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

July 8, 2010

Last Update Submit

November 15, 2011

Conditions

Biomarker

Study Arms (2)

Multiple doses of VB-201

EXPERIMENTAL
Drug: VB-201 or Placebo

Placebo

PLACEBO COMPARATOR
Drug: VB-201 or Placebo

Interventions

VB-201 or PlaceboDRUG
Multiple doses of VB-201Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients, ≥18 to ≤75 years of age;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VBL Investigative Site

Glasgow, Scotland, United Kingdom

Location

MeSH Terms

Interventions

1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

GB(1)