Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects

The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

Study Overview

• Status: Completed
• Conditions: Cicatrix; Scar Prevention
• Intervention / Treatment: Drug: RXI-109; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females, 21-50 years of age
• General good health; if female not pregnant or lactating
• Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

• Pregnant or lactating
• Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
• Type 1 or 2 diabetes mellitus
• A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: RXI-109; Multiple intradermal injections of RXI-109 at incision sites; Drug: Placebo; Multiple intradermal injections of placebo at incision sites
Experimental: RXI-109	Drug: RXI-109; Multiple intradermal injections of RXI-109 at incision sites; Drug: Placebo; Multiple intradermal injections of placebo at incision sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of multiple intradermal administrations of RXI-109	Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effect of multiple intradermal administrations of RXI-109 on scar formation	Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the timeline and levels of biomarkers	Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.	12 weeks

Collaborators and Investigators

• Sponsor: RXi Pharmaceuticals, Corp.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Fibrosis; Scar; Scar prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: RXI-109-1202