NCT01657045

Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy

A Phase I Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Needle-free Dermal Injection to Cohorts of Adults Receiving Surgical Sternotomy Incisions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: SironRX Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has FDA-clearance for subcutaneous injections.

Conditions

• Median Sternotomy

Interventions

Type	Name	Description
BIOLOGICAL	JVS-100 or placebo	Injections will be delivered depending on sternal incision length.
BIOLOGICAL	JVS-100 or placebo	Injections will be delivered depending on sternal incision length.
BIOLOGICAL	JVS-100 or placebo	Injections will be delivered depending on sternal incision length.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2012-08-03
• Last updated: 2013-07-23

Locations

6 sites across 1 country: United States