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

VBL Therapeutics

Status and phase

Completed

Phase 2

Conditions

Biomarker

Treatments

Drug: VB-201 or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159730

VB-201-030

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;