Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

Official title: Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Venous Leg Ulcers

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.

Clinical Trial Description

The objective of this study is to ascertain the systemic exposure of the active ingredient in Granexin® gel (aCT1 peptide) after topical application to venous leg ulcers using pharmacokinetic analysis. It is planned that a total of 16 patients with venous leg ulcers will receive Granexin® gel treatment plus standard of care in this one arm study. The study includes a screening period (1 week) and a treatment period (1 week) which occur sequentially for a given patient.The baseline day, which demarcates the beginning of the treatment period, is the designated as Day 0. Screening procedures are initially conducted on Day -7.

A target venous leg ulcer is identified at screening and patient eligibility is confirmed at screening and then again at the beginning of the Day 0 (baseline) visit. A patient enrolled in the study may have multiple ulcers on the same or either leg; in this case, all ulcers will be treated with Granexin® gel, but only ulcer(s) meeting the following criteria will be designated as the target ulcer(s) and will determine eligibility: >15cm2 of least 4 weeks duration in post debridement.

The treatment period for a given patient begins on Day 0 and ends one week later; the last scheduled day of the treatment period is designated as Day 7. During each treatment period, each patient is scheduled to receive topical treatment with study drug gel (3 applications total) administered by study staff at scheduled study site visits at each of the following time points: Day 0 , Day 3, and Day 7. All patients, regardless of treatment assignment, also receive standard-of-care treatment at scheduled study visits during the treatment period.

Study drug pre-application blood samples will be collected from each patient at Day 0, Day 3, and Day 7. Study drug post-application blood samples will be collected at Day 0 and Day 7 at time points specified in the protocol. These blood samples will be shipped to a designated laboratory for pharmacokinetic analysis.

Safety will be assessed during the treatment period by monitoring adverse events, measuring vital signs at each visit, performing physical examinations, electrocardiograms (ECG), as well as pharmacokinetic (PK) blood analysis. ;

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

• NCT number: NCT02652572
• Study type: Interventional
• Source: FirstString Research, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Completion date: May 2018